Application 075184

Type: ANDA
Sponsor: TEVA PHARMS

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
A075184-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2002-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075184-001	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	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075184-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2002-01-25	`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	A075184-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075184-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075184-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075184-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075184-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075184-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075184-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075184-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075184-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075184-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075184-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075184-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075184-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075184-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075184-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075184-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075184-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075184-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075184-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075184-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075184-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075184-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075184-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075184-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075184-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075184-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075184-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075184-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075184-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075184-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075184-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075184-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075184-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075184-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075184-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075184-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075184-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075184-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075184-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075184-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paclitaxel	PACLITAXEL	Teva Parenteral Medicines, Inc.	fbd32bd2-9685-41cb-bee2-730a45526b65	2026-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075184 application number: ANDA075184 ndc (product): 0703-3216 ndc (product): 0703-3213 ndc (product): 0703-3218
Paclitaxel	PACLITAXEL	Teva Parenteral Medicines, Inc.	e4be6cbf-72b9-4f7f-9b1b-459b2d35961a	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075184 application number: ANDA075184 ndc (product): 0703-3216 ndc (product): 0703-3213 ndc (product): 0703-3218 ndc (product): 0703-3217

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-3213	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3213	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3216	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3216	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3216	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3216	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3216	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3217	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3217	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3217	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3217	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3218	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3218	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3218	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3218	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3218	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-3218	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4764	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4764	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4764	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4766	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4766	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4767	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4767	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4767	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4768	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4768	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4768	Paclitaxel	Paclitaxel	Teva Parenteral Medicines, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18391	ORIG	2004-06-14
8554	ORIG	2004-06-14
42954	ORIG	2003-08-04