Application 216874

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PACLITAXEL	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
A216874-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2022-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216874-001	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.

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	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216874-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2022-10-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216874-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216874-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216874-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216874-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216874-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216874-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216874-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216874-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216874-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216874-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216874-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216874-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216874-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216874-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216874-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216874-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216874-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216874-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216874-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216874-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216874-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216874-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216874-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216874-001	AP	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216874-001	AP	1	`a50c72e98297…`

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	BluePoint Laboratories	59906bd2-8337-4cd8-9288-65b90eac2a7a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216874 application number: ANDA216874
Paclitaxel	PACLITAXEL	Alembic Pharmaceuticals Inc.	0c12c77c-5fd4-48dc-a318-e96892233992	2024-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216874 application number: ANDA216874 ndc (product): 62332-622 ndc (product): 62332-621 ndc (product): 62332-620
Paclitaxel	PACLITAXEL	Alembic Pharmaceuticals Limited	6d04b514-c85c-4db1-919e-21dd98172791	2023-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216874 application number: ANDA216874

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-620	Paclitaxel	Paclitaxel	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-621	Paclitaxel	Paclitaxel	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-622	Paclitaxel	Paclitaxel	Alembic Pharmaceuticals Inc.	ANDA	Current