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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075010-001	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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Topco Associates, LLC	59a88ca7-eb37-46de-9134-a5a6d330bd49	2026-06-23	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	57b39311-bc20-ace6-75a9-a07a9311b373	2026-06-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Rite Aid Corporation	d9e698f3-c450-4eaa-9cfd-6f48c2656081	2026-06-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	718a4b73-5f46-4676-afda-f0b4819f5862	2026-06-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	cb897d65-7e98-4d02-be64-0704416a0f29	2026-05-28	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Salado Sales, Inc.	06bc4445-5c80-4dd3-b1bb-d9244f45f570	2026-05-20	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	H E B	4805977f-a30b-4f86-9ef5-e66ad6b8bd53	2026-05-06	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	4a0c744f-4ad8-445e-bab1-7ffee35bf861	2026-05-06	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Medique at Home Iprin	IBUPROFEN	Sportpharm LLC	954d0436-b681-4bf5-80ec-0de9ddcab994	2026-04-24	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	COSTCO WHOLESALE CORPORATION	a50abf26-d6e5-10e4-ea90-a40b96a887e5	2026-04-13	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 63981-291
Ibuprofen	IBUPROFEN	Discount Drug Mart	cffad7af-44f5-4e54-9e46-c3c5d4ca182f	2026-04-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Lidl US LLC	b840e98e-be1b-496f-9f0d-3a1a55eb9fe4	2026-04-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	0ef4913b-5dc3-45bc-9cef-58601f8d2a79	2026-04-07	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Walgreen Company	86818ad6-fd45-4635-9ce8-eac986f008aa	2026-03-11	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Discount Drug Mart	d0ebf2a7-551b-4acd-be60-2d0b936dd703	2026-03-11	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Pain Relief Ibuprofen	IBUPROFEN	Rite Aid Corporation	c85c3d1f-7639-4cfa-bf3a-424b61757b1a	2026-02-03	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	CVS Pharmacy	8d9f11a5-ca98-4280-9c6a-093d32e60ace	2026-01-22	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 59779-291
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	c0c64ba5-b6b0-4221-9e44-110d92c93782	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	DOLGENCORP, LLC	37ccb303-c70e-48b3-a8a3-2b0097cf8f88	2026-01-05	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010

NDC Listings For This Application#

NDC listings for this application page 4 of 5 · 361 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57896-941	Ibuprofen	ibuprofen	Geri-Care Pharmaceutical Corp	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-291	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-292	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-292	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-292	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-292	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
59779-292	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
60760-941	Ibuprofen	ibuprofen	St. Mary's Medical Park Pharmacy	ANDA	Current
61245-082	Direct Safety Ibuprofen	Ibuprofen 200 mg	Conney Safety Products, LLC	ANDA	Current
61245-085	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-085	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-085	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-085	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-085	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
62107-002	HEALTH SENSE PROVIL	ibuprofen	Prime Marketing, LLC	ANDA	Current
62107-002	HEALTH SENSE PROVIL	ibuprofen	Prime Marketing, LLC	ANDA	Current
62936-0941	Ibuprofen	ibuprofen	INGLES MARKETS, INC.	ANDA	Current
62936-0941	Ibuprofen	ibuprofen	INGLES MARKETS, INC.	ANDA	Current
63629-1467	Ibuprofen	ibuprofen	Bryant Ranch Prepack	ANDA	Current
63629-1467	Ibuprofen	ibuprofen	Bryant Ranch Prepack	ANDA	Current
63629-7977	Ibuprofen	ibuprofen	Bryant Ranch Prepack	ANDA	Current
63629-7977	Ibuprofen	ibuprofen	Bryant Ranch Prepack	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSO	ANDA	Current
63868-773	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSO	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-979	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63940-291	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-291	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-291	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-291	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-291	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-291	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-292	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-292	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-292	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-292	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63940-292	Ibuprofen	Ibuprofen	Harmon Store Inc.	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-291	Ibuprofen	ibuprofen	COSTCO WHOLESALE CORPORATION	ANDA	Current
64092-200	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-200	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-200	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-200	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-200	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-204	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-204	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-204	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-204	Ibuprofen	Ibuprofen	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
66267-115	Ibuprofen	ibuprofen	NuCare Pharmaceuticals, I	ANDA	Current
66267-115	Ibuprofen	ibuprofen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-115	Ibuprofen	ibuprofen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66715-5539	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-5739	Circle K Ibuprofen	Ibuprofen	Lil' Drug Store Products, Inc	ANDA	Current
66715-5839	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-5839	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-5839	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-5839	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	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