Application 076233

Type: ANDA
Sponsor: HOSPIRA

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 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
A076233-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION			2002-08-01

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076233-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	2002-08-01	`f41ea6bd6efb…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABRAXANE	PACLITAXEL	Abraxis BioScience, LLC	24d10449-2936-4cd3-b7db-a7683db721e4	2022-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Northstar Rx LLC	e47c2c34-0466-4219-be6f-97e4231ed55f	2021-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
Paclitaxel	PACLITAXEL	Novadoz Pharmaceuticals LLC	4e1bf850-d616-4ff3-b62a-2057dddc3dfe	2020-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paclitaxel generic name: PACLITAXEL
PACLITAXEL PACLITAXEL	PACLITAXEL	Gland Pharma Limited	fec9ddee-53a9-4a61-ad0a-be6b604de084	2016-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PACLITAXEL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43065	ORIG	2005-07-22