Application 213434

Type: ANDA
Sponsor: MSN

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
A213434-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213434-001	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	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213434-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2020-08-24	`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	A213434-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213434-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213434-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213434-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213434-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213434-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213434-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213434-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213434-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213434-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213434-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213434-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213434-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213434-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213434-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213434-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213434-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213434-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213434-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213434-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213434-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213434-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213434-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213434-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213434-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213434-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213434-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213434-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213434-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213434-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213434-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213434-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213434-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213434-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213434-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213434-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213434-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paclitaxel	PACLITAXEL	Bryant Ranch Prepack	30384708-1fcd-4a75-94d7-9d5d617a37b6	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213434 application number: ANDA213434
Paclitaxel	PACLITAXEL	BluePoint Laboratories	9e7bc2c2-a369-4c6f-9dd9-ee98ddaae833	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213434 application number: ANDA213434 ndc (product): 68001-516
Paclitaxel	PACLITAXEL	Northstar Rx LLC	e47c2c34-0466-4219-be6f-97e4231ed55f	2021-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213434 application number: ANDA213434 ndc (product): 16714-137
Paclitaxel	PACLITAXEL	Novadoz Pharmaceuticals LLC	4e1bf850-d616-4ff3-b62a-2057dddc3dfe	2020-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213434 application number: ANDA213434 ndc (product): 72205-063 ndc (product): 72205-062 ndc (product): 72205-061

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-137	Paclitaxel	Paclitaxel	Northstar Rx LLC	ANDA	Current
16714-137	Paclitaxel	Paclitaxel	Northstar Rx LLC	ANDA	Current
68001-516	Paclitaxel	Paclitaxel	BluePoint Laboratories	ANDA	Current
69539-157	Paclitaxel	Paclitaxel	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-157	Paclitaxel	Paclitaxel	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-158	Paclitaxel	Paclitaxel	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-158	Paclitaxel	Paclitaxel	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-159	Paclitaxel	Paclitaxel	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-159	Paclitaxel	Paclitaxel	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
72205-061	Paclitaxel	Paclitaxel	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-062	Paclitaxel	Paclitaxel	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-063	Paclitaxel	Paclitaxel	Novadoz Pharmaceuticals LLC	ANDA	Current