Application 071334

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	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
A071334-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB		1986-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071334-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071334-001	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-11-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A071334-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071334-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A071334-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	57cdd1df-a303-4265-a2d6-1d0b87105a28	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071334 application number: ANDA071334 ndc (product): 53746-131

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53746-131	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-131	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-131	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-131	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-131	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-131	Ibuprofen	Ibuprofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53808-0272	Ibuprofen	Ibuprofen	State of Florida DOH Central Pharmacy	ANDA	Current