Application 078122

Type: ANDA
Sponsor: PLIVA LACHEMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	No	No
002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/5ML (20MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078122-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION			2008-10-31
A078122-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION			2008-10-31

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078122-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078122-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2008-10-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078122-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078122-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078122-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078122-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078122-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078122-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078122-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078122-002	AP	1	`ea99ee380514…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Camptosar	IRINOTECAN HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	e518dfc6-7e93-4fee-a66c-51e1ab71c056	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	d04f2471-3085-4fc8-a657-bb3918d48e6e	2026-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	Xiromed LLC	b26e5d27-dba5-7538-9e7b-48b358998cbb	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Sagent Pharmaceuticals	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Hospira, Inc.	5c527c2e-9062-4afe-dbbb-f650db3a340f	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	Eugia US LLC	7a30d551-9ea7-47ea-9073-f541bff457a3	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRINOTECAN HYDROCHLORIDE generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloride	IRINOTECAN HYDROCHLORIDE	Actavis Pharma, Inc.	5e1fdcaa-918f-4cd8-9c7a-4c538d866198	2025-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Onivyde	IRINOTECAN HYDROCHLORIDE	Ipsen Biopharmaceuticals, Inc.	c8b58efa-1820-48a4-b70d-62918fc4abfc	2025-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Apotex Corp.	8fe98987-e526-4729-a8f4-c7230f424108	2024-07-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Apotex Corp.	85ed6019-f462-4abe-a89e-ad991623c86d	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Fresenius Kabi USA, LLC	ee45f127-8450-4455-a945-a1f5707f1d39	2023-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloride	IRINOTECAN HYDROCHLORIDE	Northstar Rx LLC	4f98e9ed-f7b1-5346-af72-fccb0abf3f4b	2022-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	Gland Pharma Limited	de634e80-328a-4473-b395-0172683a2411	2022-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	afcdde49-ec0c-4c56-a1af-2917185b1a08	2021-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	9c6aa884-750e-4b11-9955-bc7ab6e9c2ad	2020-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	be716692-6b4f-47b6-83d1-01665861626b	2020-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irinotecan Hydrochloride generic name: IRINOTECAN HYDROCHLORIDE