Application 075139

Type: ANDA
Sponsor: LNK

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
A075139-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1999-03-01

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	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Better Living Brands, LLC	45520969-7a2d-4469-ba25-7db160d50ccf	2026-07-06	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	027ded51-aa01-6619-3938-c8162a421cf3	2026-06-18	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 50844-392
Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. DBA Leader	a41a0bc2-ef7a-44cd-a42e-aefab41323cc	2026-06-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	01f8fe3a-8810-4b38-8860-d95e05d37709	2026-06-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 55301-393
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	260f5862-d65d-4c34-bf53-26ca30806a67	2026-05-19	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 55154-0669
Ibuprofen	IBUPROFEN	Meijer Distribution, Inc.	3e3a5366-535d-45fb-81af-c7d98ac20b11	2026-05-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen Dye Free	IBUPROFEN	CVS Pharmacy	00653b7c-7099-487e-9a01-e89781c21323	2026-04-29	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 59779-438
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	36f7227d-f3cb-44b7-a4c1-27611cd15052	2026-04-24	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Rite Aid Corporation	72e11f2d-a348-4c12-9cd8-1e6f0f6f7399	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen Dye-Free	IBUPROFEN	Wal-Mart Stores Inc	23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6	2026-04-01	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 49035-438
Ibuprofen Dye Free	IBUPROFEN	WALMART INC.	2b04d255-a1df-4698-9b5a-ad7a12205e1b	2026-03-25	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
pain relief ibuprofen	IBUPROFEN	Rite Aid Corporation	2bd1438e-27b1-81ff-f8e1-0f5b50b04581	2026-02-02	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	H E B	88c7486b-f9a7-4856-a25a-7c06e1382f1a	2026-02-02	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	82e907e6-86a9-5c7f-93bd-a6319d74100f	2026-01-13	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 50844-438
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	8ebe3e16-b7ae-d333-6671-5bc935e25900	2026-01-13	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 50844-352
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	c93da67f-f42e-4baa-976b-73c71ba6dd71	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 50844-353
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6	2025-12-17	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Dye Free Ibuprofen	IBUPROFEN	Walgreen Company	d3d093f9-207a-40d4-a7be-c6b5a544a0a7	2025-12-12	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Family Dollar Services Inc	89ed9311-2185-4660-b219-9ea67b1a71ec	2025-11-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Topco Associates, LLC	bcf7d4c1-1f99-48df-8f74-9abeefa8d41d	2025-11-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 210 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49035-438	Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-438	Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-438	Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-438	Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-438	Ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49260-615	Help I Have an Aching Body	Ibuprofen	Help Remedies, Inc.	ANDA	Current
50090-2809	Ibuprofen	ibuprofen	A-S Medication Solutions	ANDA	Current
50844-352	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-352	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-352	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-352	Ibuprofen	ibuprofen	L.N.K. International, Inc	ANDA	Current
50844-352	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-353	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-353	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-353	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-353	Ibuprofen	ibuprofen	L.N.K. International, Inc	ANDA	Current
50844-353	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-392	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-392	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-392	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-392	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-392	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-393	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-393	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-393	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-393	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-393	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-438	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-438	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-438	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-438	Ibuprofen	ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-993	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-993	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-993	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-993	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-993	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
55154-0669	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-0669	Ibuprofen	Ibuprofen	Cardinal Health 107, LLC	ANDA	Current
55301-392	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-392	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-392	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-392	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-392	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-393	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-393	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-393	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-393	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-393	Ibuprofen	Ibuprofen	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55315-393	Ibuprofen	Ibuprofen	FRED'S, INC.	ANDA	Current
55315-393	Ibuprofen	Ibuprofen	FRED'S, INC.	ANDA	Current
55315-393	Ibuprofen	Ibuprofen	FRED'S, INC.	ANDA	Current
55315-393	Ibuprofen	Ibuprofen	FRED'S, INC.	ANDA	Current
55319-393	Ibuprofen IB	Ibuprofen	Family Dollar Services In	ANDA	Current
55319-393	Ibuprofen IB	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55910-392	Ibuprofen	ibuprofen	DOLGENCORP, LLC	ANDA	Current
55910-932	Ibuprofen	Ibuprofen	DOLGENCORP, LLC	ANDA	Current
55910-932	Ibuprofen	Ibuprofen	DOLGENCORP, LLC	ANDA	Current
55910-932	Ibuprofen	Ibuprofen	DOLGENCORP, LLC	ANDA	Current
55910-932	Ibuprofen	Ibuprofen	DOLGENCORP, LLC	ANDA	Current
55910-932	Ibuprofen	Ibuprofen	DOLGENCORP, LLC	ANDA	Current
59779-392	Ibuprofen	ibuprofen	CVS Pharmacy	ANDA	Current
59779-392	Ibuprofen	ibuprofen	CVS Pharmacy	ANDA	Current
59779-392	Ibuprofen	ibuprofen	CVS Pharmacy	ANDA	Current
59779-392	Ibuprofen	ibuprofen	CVS Pharmacy	ANDA	Current
59779-392	Ibuprofen	ibuprofen	CVS Pharmacy	ANDA	Current
59779-393	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-393	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-393	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-393	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-393	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-438	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-438	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-438	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-438	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-438	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
63940-392	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-392	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-392	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-392	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-392	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42949	SUPPL	2007-07-27
42948	SUPPL	2007-07-27
42947	SUPPL	2007-07-27
22429	SUPPL	2007-07-27
42946	SUPPL	2007-07-24
42945	SUPPL	2007-07-24
22428	SUPPL	2007-07-24
22427	SUPPL	2007-07-24
22426	ORIG	2007-07-24
30771	ORIG	1999-03-01