Application 072095

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAB-PROFEN	IBUPROFEN	TABLET;ORAL	200MG	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
A072095-001	TAB-PROFEN	IBUPROFEN	200MG	TABLET / ORAL			1987-12-08

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	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072095-001	TAB-PROFEN	200MG	TABLET / ORAL	1987-12-08	`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 29 of 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
up and up ibuprofen	IBUPROFEN	Target Corporation	2919fe8b-9c76-4ef6-851e-3247782cef44	2025-04-11	Warnings	Name fallback generic name: IBUPROFEN
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	e18f4ce6-d7d3-4b53-b87a-5900ac3397f1	2025-04-11	Warnings	Name fallback generic name: IBUPROFEN
TopCare Ibuprofen	IBUPROFEN	Topco Associates LLC	66097f19-227c-4f9c-a7f3-ab8476e1bb6e	2025-04-08	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Major Pharmaceuticals	14f43c32-0895-4ef2-aa54-52b952d058fd	2025-04-08	Warnings	Name fallback generic name: IBUPROFEN
parents choice infants ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	a826d6cc-f582-4508-897d-0d637de0666c	2025-04-07	Warnings	Name fallback generic name: IBUPROFEN
leader infants ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	b72fdf65-8112-4d8b-b86f-8e17a40ee8e6	2025-04-07	Warnings	Name fallback generic name: IBUPROFEN
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	ea2ba726-0199-42ae-9c60-4b068df35e64	2025-04-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31f59d10-d821-2291-e063-6294a90ac518	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31f61d5c-a3a3-3d47-e063-6394a90afb62	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6005b-492e-7936-e063-6394a90ad801	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6ac7a-fa3e-4dd4-e063-6294a90a29af	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	b303b554-c457-4f2b-9931-48f30943178b	2025-04-03	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	87c9f15f-1196-477c-b5d2-3b875bea61d0	2025-04-03	Warnings	Name fallback generic name: IBUPROFEN
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	74f46147-b4c2-4bb3-bd0a-220c0a5403a6	2025-04-01	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	0cb4b0ef-5cdd-4c79-8718-4fb157a2c948	2025-03-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3140a614-c7ae-3062-e063-6394a90ad3d7	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	3b78c004-e4fe-449c-86e9-52e8ccf12785	2025-03-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	WR Group, Inc.	e9dad35a-6789-42d6-97da-521db7b16496	2025-03-24	Warnings	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	25bc5cc2-9b6a-47e4-8b3d-2bb370907b61	2025-03-20	Warnings	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	cd15159a-9ed5-453a-9ad4-0c9688204c82	2025-03-19	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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