Fresenius Kabi USA, LLC | CIPLA LIMITED | Fresenius Kabi Oncology Limited blanket no changes certification of product listing

Manufacturer: Fresenius Kabi USA, LLC | CIPLA LIMITED | Fresenius Kabi Oncology Limited
Effective date: 2017-10-11
Label type: BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:48:37

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-172-05	ML - Milliliter	63323-172	cb987630-190a-4676-8d26-6605490fada0	1	2012-07-24
63323-172-15	ML - Milliliter	63323-172	426aa91e-aa4f-4c51-a1ef-0403c1fc1691	1	2012-07-24
63323-172-45	ML - Milliliter	63323-172	8f9c9de2-6c81-432f-8c19-cf2382836039	1	2012-07-24
63323-172-60	ML - Milliliter	63323-172	b597082a-b6f1-4f3b-b3aa-053c0a516794	1	2017-07-07
63323-193-02	ML - Milliliter	63323-193	0d2a9612-1068-424a-ad6c-f7db1ba72b81	1	2012-07-24
63323-193-05	ML - Milliliter	63323-193	a4ebbd96-794e-4ea2-9a9c-8b207c0eee03	1	2012-07-24
63323-193-52	ML - Milliliter	63323-193	38745ed2-b276-466c-812f-bd6419ab8151	1	2015-09-10
63323-193-55	ML - Milliliter	63323-193	815ec171-6184-4ea8-95cc-0beea4b7a654	1	2015-09-10
63323-763-05	ML - Milliliter	63323-763	59314b53-1787-4052-b8e8-a21256a96372	1	2012-07-24
63323-763-06	ML - Milliliter	63323-763	60e22a79-f93f-4650-9a15-c8dd2105fa44	1	2014-10-03
63323-763-16	ML - Milliliter	63323-763	dbb678a8-81a3-4d66-8520-1e98839aa0e1	1	2012-07-24
63323-763-17	ML - Milliliter	63323-763	116ad3d0-cc78-4379-a51b-221a58a87203	1	2014-10-03
63323-763-50	ML - Milliliter	63323-763	10a35ac1-0689-45af-9592-7a332a5b43b0	1	2012-07-24
63323-763-52	ML - Milliliter	63323-763	e04966be-66d6-4c3a-9578-7d80f9f140cc	1	2014-10-03
63323-102-10	EA - Each	63323-102	eb189f44-673f-4241-8372-d832eab0589f	1	2012-07-24
63323-102-13	EA - Each	63323-102	2fe6538b-b630-4c6f-b830-38bb8683137e	1	2013-02-13
63323-102-94	EA - Each	63323-102	a6dd60d4-c2c5-4c88-ba0e-31b408115496	1	2016-05-16
63323-125-50	EA - Each	63323-125	b028a3c0-d1b3-4d30-ab62-14a092e8e3b4	1	2012-07-24
63323-125-53	EA - Each	63323-125	2534cd3c-11e5-4e5d-a45f-2cf6592377f8	1	2012-07-24
63323-125-94	EA - Each	63323-125	353039d6-ac54-46b0-9e54-1aa674b962f2	1	2016-05-16
63323-126-00	EA - Each	63323-126	88292c15-15e2-4b14-a15d-2743293b6f1c	1	2017-05-04
63323-126-03	EA - Each	63323-126	dc33fbec-ba34-4f72-bb9c-224e0fd62f0c	1	2021-03-02
63323-129-30	EA - Each	63323-129	b165ef9f-e4c2-4065-8379-304795b5dd9c	1	2012-07-24
63323-772-30	EA - Each	63323-772	c2dd3844-07d0-4676-a10c-68c8a4bb96ac	1	2012-07-24

NDC Codes#

Product NDC table
Product NDC
63323-172
63323-193
63323-763
63323-102
63323-125
63323-126
63323-129
63323-772

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 4 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077266-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15
A077266-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15
A077266-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15
A077266-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077266-003	AP
A077266-004	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077266-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077266-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077266-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077266-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077266-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077266-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077266-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077266-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077266-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077266-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077266-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077266-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077266-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077266-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077266-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077266-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077266-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077266-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077266-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077266-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077266-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077266-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077266-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077266-004	AP	1	`74a2ff9319b5…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077574-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2006-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077574-001	AP

Observed Orange Book product history#

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077574-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077574-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077574-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077574-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077574-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077574-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077574-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077574-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077574-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077574-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077574-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077574-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077574-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077574-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077574-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077574-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077574-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077574-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077574-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077574-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077574-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077574-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077574-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077574-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077574-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077574-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077574-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077574-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077574-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077574-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077574-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077574-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077574-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077574-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077574-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077574-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077574-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077574-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077574-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077574-001	AP	1	`f41ea6bd6efb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077776-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP		2008-02-27
A077776-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP		2008-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077776-001	AP
A077776-002	AP

Observed Orange Book product history#

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077776-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077776-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-02-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077776-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077776-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077776-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077776-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077776-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077776-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077776-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077776-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077776-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077776-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077776-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077776-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077776-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077776-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077776-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077776-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077776-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077776-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077776-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077776-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077776-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077776-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077776-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077776-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077776-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077776-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077776-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077776-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077776-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077776-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077776-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077776-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077776-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077776-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077776-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077776-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077776-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077776-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077776-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077776-002	AP	1	`74a2ff9319b5…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090799-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25
A090799-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25
A090799-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090799-001	AP
A090799-002	AP
A090799-003	AP

Observed Orange Book product history#

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090799-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090799-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090799-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090799-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090799-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090799-001	AP	1	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMCITABINE	GEMCITABINE	Fresenius Kabi USA, LLC	c550dd16-a5e8-44be-87f2-210c15bbb513	2024-10-14	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-102 ndc (product): 63323-126 ndc (product): 63323-125
Paclitaxel	PACLITAXEL	Fresenius Kabi USA, LLC	a6c24189-293f-42ca-b969-75870bb55af0	2024-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-763
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Fresenius Kabi USA, LLC	ee45f127-8450-4455-a945-a1f5707f1d39	2023-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-193
Carboplatin	CARBOPLATIN	Fresenius Kabi USA, LLC	b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6	2021-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63323-172
GEMCITABINE	GEMCITABINE	Fresenius Kabi USA, LLC	d1f3951c-d13f-4662-ad4b-ecfc07f59104	2021-01-20	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-102 ndc (product): 63323-125

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.