Application 091239

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 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
A091239-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	44660e1d-79c2-34ce-e063-6294a90ade3f	2026-03-17	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	Kroger Company	bc173f1b-2e44-2c2e-e053-2a95a90a89c4	2025-09-24	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES,INC	f58d35f9-e44b-417b-98ce-0766b537cd2f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	7653b33c-7489-10db-e053-2991aa0ab508	2025-06-06	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
AeroTab Ibuprofen	IBUPROFEN TABLET	Aero Healthcare	ddd0f7fb-ae4b-c584-e053-2a95a90a0984	2025-02-26	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	a6d4ceb0-2b79-496a-aa1e-27edd507ced0	2024-12-10	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	SAM'S WEST INC	16595d75-6e74-0839-e063-6394a90abc13	2024-05-28	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	746f79aa-3036-1b9b-e053-2a91aa0a1db6	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	8e8684fa-095e-c6d6-e053-2a95a90a15b4	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e86ae68-7687-79d6-e053-2995a90ac274	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb613c44-e125-0f40-e053-2995a90a7ca5	2023-10-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb60e636-41fe-49fb-e053-2a95a90a0616	2023-09-29	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
ibuprofen	IBUPROFEN	DOLGENCORP INC	8f1358aa-495a-23da-e053-2995a90aa430	2023-01-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7aa790a-6d6c-7929-e053-2995a90a1cf8	2022-01-04	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	3c8df1e5-61bc-4e70-b6b9-8973986ad589	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7abac4c-7695-cfe8-e053-2a95a90ac1cd	2021-10-30	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76168-095	Ibuprofen	Ibuprofen	Velocity Pharma	ANDA	Current