Application 207326

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PACITAXEL	PACLITAXEL	INJECTABLE;INJECTION	6MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207326-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2016-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207326-001	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 2 · 41 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	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207326-001	PACITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207326-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2016-08-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207326-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207326-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207326-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207326-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207326-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207326-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207326-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207326-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207326-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207326-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207326-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207326-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207326-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207326-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207326-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207326-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207326-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207326-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207326-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207326-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207326-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207326-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207326-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207326-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207326-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207326-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207326-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207326-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207326-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207326-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207326-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207326-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207326-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207326-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207326-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207326-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207326-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207326-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207326-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207326-001	AP	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PACLITAXEL PACLITAXEL	PACLITAXEL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b4c5d08a-e0f5-4af1-97d6-213705adedf1	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207326 application number: ANDA207326
Paclitaxel	PACLITAXEL	Sagent Pharmaceuticals	5721b9bf-c3c1-4b73-b96c-5fbe3147b6a5	2024-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207326 application number: ANDA207326
PACLITAXEL PACLITAXEL	PACLITAXEL	Gland Pharma Limited	fec9ddee-53a9-4a61-ad0a-be6b604de084	2016-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207326 application number: ANDA207326 ndc (product): 68083-178 ndc (product): 68083-180 ndc (product): 68083-179

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-593	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-593	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-594	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-594	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-595	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-595	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-595	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-595	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
47781-595	Paclitaxel	paclitaxel	Alvogen Inc.	ANDA	Current
51991-936	Paclitaxel	Paclitaxel	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-937	Paclitaxel	Paclitaxel	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-938	Paclitaxel	Paclitaxel	Breckenridge Pharmaceutical, Inc.	ANDA	Current
68083-178	PACLITAXEL	paclitaxel	Gland Pharma Limited	ANDA	Current
68083-179	PACLITAXEL	paclitaxel	Gland Pharma Limited	ANDA	Current
68083-180	PACLITAXEL	paclitaxel	Gland Pharma Limited	ANDA	Current
70860-200	Paclitaxel	paclitaxel	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-215	Paclitaxel	paclitaxel	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-215	Paclitaxel	paclitaxel	Athenex Pharmaceutical Division, LLC.	ANDA	Current