Application 091237

Type: ANDA
Sponsor: MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091237-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-08

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`e64feba35796…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	CVS Pharmacy. Inc.	d4336a7c-fb9f-1fbe-e053-2995a90af365	2025-09-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 69842-493
Ibuprofen	IBUPROFEN	CVS Pharmacy.Inc.	cd0c3404-9e9d-bfad-e053-2995a90a8719	2025-09-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 69842-489
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	82aad715-f652-471b-840c-5151c66e5ade	2024-08-28	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 49483-611 ndc (product): 49483-612
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	KROGER COMPANY	0fbe42d0-b5f2-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	WALGREENS	76f4cc25-a77e-6245-e053-2a91aa0af7ae	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 0363-9611
IBUPROFEN	IBUPROFEN	WALGREENS	76f15be2-4682-5015-e053-2991aa0af0d2	2024-03-15	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 0363-9612
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e872c8d-28e2-cd49-e053-2995a90a469f	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 11673-993
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	BETTER LIVING BRANDS, LLC	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2023-08-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN	CARDINAL HEALTH	dfbbde4f-633d-6d57-e053-2a95a90ad82f	2022-05-24	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 70000-0597
IBUPROFEN	IBUPROFEN	RITE AID	a7abf95e-d444-42da-e053-2995a90a88d3	2022-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 11822-7893
IBUPROFEN	IBUPROFEN	RITE AID	a7ac8b55-2758-400e-e053-2995a90a0eed	2022-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 11822-8925
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	859d7190-586f-4766-a7e7-9e800a72d58b	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (product): 25000-135 ndc (product): 25000-136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9611	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9611	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9611	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9612	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9612	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9612	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
11673-993	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-993	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-993	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11822-7893	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
11822-7893	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
11822-7893	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
11822-8925	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
11822-8925	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
11822-8925	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
11822-8925	IBUPROFEN	IBUPROFEN	RITE AID	ANDA	Current
25000-135	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-135	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-135	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-136	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-136	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-136	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
49483-611	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-612	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
52605-120	Ibuprofen	Ibuprofen	Polygen Pharmaceuticals LLC	ANDA	Current
53943-115	Ibuprofen	Ibuprofen	Discount Drug Mart	ANDA	Current
61715-168	Ibuprofen	Ibuprofen	Kinray, Inc.	ANDA	Current
68016-295	Ibuprofen	Ibuprofen	Chain Drug Consortium LLC	ANDA	Current
69842-489	Ibuprofen	Ibuprofen	CVS Pharmacy.Inc.	ANDA	Current
69842-493	Ibuprofen	Ibuprofen	CVS Pharmacy. Inc.	ANDA	Current
70000-0597	Ibuprofen	Ibuprofen	CARDINAL HEALTH	ANDA	Current