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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c2088c7a36db…`
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…`

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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 41250-991
Ibuprofen	IBUPROFEN	DOLGENCORP, LLC	37ccb303-c70e-48b3-a8a3-2b0097cf8f88	2026-01-05	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab313564-27dc-0297-e053-2a95a90a6690	2026-01-01	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen 24/7 Life by 7-Eleven	IBUPROFEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45b3b825-dab7-3328-e063-6294a90a7d2a	2025-12-11	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Physicians Care Ibuprofen	IBUPROFEN 200MG	Acme United Corporation	490c1109-dad7-4135-e054-00144ff8d46c	2025-10-31	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	6521bc47-4d9c-4a5b-b109-3841f3be4b6c	2025-10-07	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Green Guard Ibupro relief	IBUPROFEN	Unifirst First Aid Corporation	2923c4a3-f994-67a7-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 47682-610
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	2910b50b-c8de-382b-e054-00144ff88e88	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 47682-608 ndc (product): 47682-614 ndc (product): 47682-600 ndc (product): 47682-609
Medique at Home Iprin	IBUPROFEN	Unifirst First Aid Corporation	b5547f33-2a81-867d-e053-2995a90aa2d0	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 47682-683
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	28d45743-d298-29db-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Unishield Ibuprofen	IBUPROFEN	Unishield	b9e2e2ba-e2ad-eace-e053-2995a90aed35	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Uline Ibuprofen	IBUPROFEN	Uline	d7342a15-9d49-74ed-e053-2a95a90a22cc	2025-09-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Henry Schein Ibuprofen	IBUPROFEN	Henry Schein Inc.	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen Thompson	IBUPROFEN	Thompson Safety	ccfbc048-f666-3188-e053-2995a90ae08f	2025-09-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Sam's West Inc	6293a134-860d-4d12-9e4b-28490f824108	2025-09-03	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Chain Drug Consortium	6c593a9c-680e-4645-8e8f-d8d044c92ca1	2025-07-18	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Wildman Business Group	9e71f1c1-5272-4209-8974-6c525b141155	2024-08-19	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	3e3848f2-4922-39ea-e054-00144ff88e88	2024-06-25	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
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

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 2 of 5 · 361 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
37808-922	Ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-922	Ibuprofen	Ibuprofen	H E B	ANDA	Current
41163-291	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
41163-291	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
41163-291	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-991	Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
42254-315	Ibuprofen	ibuprofen	Rebel Distributors Corp	ANDA	Current
46994-291	Ibuprofen	Ibuprofen	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-291	Ibuprofen	Ibuprofen	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-291	Ibuprofen	Ibuprofen	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-291	Ibuprofen	Ibuprofen	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-291	Ibuprofen	Ibuprofen	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-600	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-608	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-609	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-610	Green Guard Ibupro relief	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-614	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-683	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-683	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-683	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-683	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
49035-912	Ibuprofen	Ibuprofen	Wal-Mart Stores 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