Application 075010

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 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
A075010-001	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 · 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	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`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 3 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN 200MG	Lil' Drug Store Products, Inc.	8fc65767-1783-4f7f-8680-9e43ba4d5481	2024-06-19	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 29485-9291
Ibuprofen	IBUPROFEN	Geri-Care Pharmaceutical Corp	0744c3ca-4224-4f6a-a033-880949b544fd	2023-10-30	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	8fafa916-733a-4c7d-99da-6ca2ed54e1e4	2023-10-06	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen, Caseys 4good	IBUPROFEN TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	0402556a-25f8-7afc-e063-6294a90a77ce	2023-08-28	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	INGLES MARKETS, INC.	ef536841-768c-919f-e053-2a95a90af599	2022-12-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Circle K Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	805d9d80-7de7-49d9-afdb-3a645059fe35	2022-09-21	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e5bf5e09-7d42-6314-e053-2a95a90a2325	2022-08-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Geritrex LLC	ca9498ec-755d-4a09-9504-210dd48d6fed	2018-10-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	e4314153-479d-4c0f-ba49-4d4efded304b	2018-04-06	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010

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 5 · 361 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0291	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0291	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0291	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0291	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0291	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0291	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0292	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0292	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0292	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0292	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0363-0292	Ibuprofen	Ibuprofen	Walgreen Company	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0404-0017	Henry Schein Ibuprofen	Ibuprofen	Henry Schein Inc.	ANDA	Current
0536-1088	Ibuprofen	Ibuprofen	Rugby Laboratories	ANDA	Current
0536-1088	Ibuprofen	Ibuprofen	Rugby Laboratories	ANDA	Current
0536-1089	Ibuprofen	Ibuprofen	Rugby Laboratories	ANDA	Current
0536-1089	Ibuprofen	Ibuprofen	Rugby Laboratories	ANDA	Current
0536-1089	Ibuprofen	Ibuprofen	Rugby Laboratories	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0075	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0275	First Aid Only Ibuprofen	Ibuprofen	Acme United Corporation	ANDA	Current
0924-0275	First Aid Only Ibuprofen	Ibuprofen	Acme United Corporation	ANDA	Current
11822-0291	Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0291	Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0291	Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0291	Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0291	Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0291	Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
11822-0292	Pain Relief Ibuprofen	Ibuprofen	Rite Aid Corporation	ANDA	Current
15127-312	Ibuprofen	Ibuprofen	L&R Distributors, Inc.	ANDA	Current
15127-312	Ibuprofen	Ibuprofen	L&R Distributors, Inc.	ANDA	Current
15127-335	Ibuprofen	Ibuprofen	L&R Distributors, Inc.	ANDA	Current
15127-335	Ibuprofen	Ibuprofen	L&R Distributors, Inc.	ANDA	Current
16103-407	Ibuprofen	Ibuprofen	Pharbest Pharmaceuticals, Inc.	ANDA	Current
21130-292	Ibuprofen	Ibuprofen	Better Living Brands, LLC	ANDA	Current
21130-921	Ibuprofen	Ibuprofen	Better Living Brands, LLC	ANDA	Current
21130-921	Ibuprofen	Ibuprofen	Better Living Brands, LLC	ANDA	Current
21130-921	Ibuprofen	Ibuprofen	Better Living Brands, LLC	ANDA	Current
21130-921	Ibuprofen	Ibuprofen	Better Living Brands, LLC	ANDA	Current
21130-921	Ibuprofen	Ibuprofen	Better Living Brands, LLC	ANDA	Current
29485-8152	24/7 Life IBUPROFEN	IBUPROFEN	Mechanical Servants, LLC	ANDA	Current
29485-9291	IBUPROFEN	IBUPROFEN 200MG	Mechanical Servants LLC	ANDA	Current
33992-0291	Ibuprofen	Ibuprofen	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0291	Ibuprofen	Ibuprofen	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0291	Ibuprofen	Ibuprofen	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
36800-292	Ibuprofen	Ibuprofen	Topco Associates, LLC	ANDA	Current
36800-292	Ibuprofen	Ibuprofen	Topco Associates, LLC	ANDA	Current
36800-292	Ibuprofen	Ibuprofen	Topco Associates, LLC	ANDA	Current
36800-292	Ibuprofen	Ibuprofen	Topco Associates, LLC	ANDA	Current
36800-292	Ibuprofen	Ibuprofen	Topco Associates, LLC	ANDA	Current
36800-292	Ibuprofen	Ibuprofen	Topco Associates, LLC	ANDA	Current
37205-670	Ibuprofen	Ibuprofen	CARDINAL HEALTH	ANDA	Current
37205-670	Ibuprofen	Ibuprofen	CARDINAL HEALTH	ANDA	Current
37808-921	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-921	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-921	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-921	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-921	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-921	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-922	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-922	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-922	Ibuprofen	Ibuprofen	H E B	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42919	SUPPL	2007-07-20
42918	SUPPL	2007-07-20
42917	SUPPL	2007-07-20
42916	ORIG	2007-07-20
8488	ORIG	1999-03-01