Application 079174

Type: ANDA
Sponsor: GRANULES INDIA

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
A079174-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2010-12-10

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	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`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 4 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN 200 MG	IBUPROFEN	Basic Drugs, Inc.	d3351d44-2078-3adc-e053-2995a90a3c8f	2024-01-03	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 0761-0908
Circle K Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	791a7375-34b2-449b-9284-3c49a2704619	2022-10-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Pain Relief - Ibuprofen 200 mg	IBUPROFEN	Health Pharma USA LLC	d60a6a11-8c06-cede-e053-2a95a90af7f9	2022-01-20	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen 200mg	IBUPROFEN	Allegiant Health	f3f12b86-89dc-427e-a26f-728be6f73e7b	2021-11-16	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	c13455a3-307a-4fe1-e053-2a95a90adf8e	2021-11-10	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen 200mg	IBUPROFEN 200MG	Allegiant Health	2e33a153-0a3f-4b88-b193-d63e0b792ccc	2019-12-12	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN	IBUPROFEN 200MG	ADVANCED FIRST AID, INC.	564e9910-b491-4129-a4f1-68216267623b	2018-07-23	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	acc4cbc8-085d-42f3-ad93-113e0b55631c	2017-11-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	CVS PHARMACY, INC.	cdd5a402-df90-4a16-a38c-78eab7189998	2017-11-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Fast Pain Relief	IBUPROFEN	HealthLife of USA LLC	a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65	2017-06-05	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174

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 4 · 268 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9594	IBUPROFEN	IBUPROFEN	WALGREENS CO.	ANDA	Current
0761-0908	IBUPROFEN	IBUPROFEN	Basic Drugs, Inc.	ANDA	Current
0761-0908	IBUPROFEN	IBUPROFEN	Basic Drugs, Inc.	ANDA	Current
0761-0908	IBUPROFEN	IBUPROFEN	Basic Drugs, Inc.	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0276	First Aid Only Ibuprofen	Ibuprofen	Acme United Corporation	ANDA	Current
0924-0276	First Aid Only Ibuprofen	Ibuprofen	Acme United Corporation	ANDA	Current
11673-217	Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
11673-248	Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
11673-249	Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
21130-396	Ibuprofen	Ibuprofen	BETTER LIVING BRANDS LLC.	ANDA	Current
29485-7625	IBUPROFEN	IBUPROFEN 200MG	Mechanical Servants LLC	ANDA	Current
29485-7625	IBUPROFEN	IBUPROFEN 200MG	Mechanical Servants LLC	ANDA	Current
30142-249	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
30142-249	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
33992-0568	Ibuprofen	Ibuprofen	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0568	Ibuprofen	Ibuprofen	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
35418-751	Zee Ibutab	Ibuprofen	Zee Medical Inc	ANDA	Current
36800-248	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-248	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-249	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-249	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-969	Ibuprofen	Ibuprofen	TopCare	ANDA	Current
36800-969	Ibuprofen	Ibuprofen	TopCare	ANDA	Current
37808-109	Ibuprofen	Ibuprofen	HEB	ANDA	Current
37808-109	Ibuprofen	Ibuprofen	HEB	ANDA	Current
37808-410	Ibuprofen	Ibuprofen	HEB	ANDA	Current
37808-410	Ibuprofen	Ibuprofen	HEB	ANDA	Current
41163-509	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
42961-043	Zee Ibutab	Ibuprofen	Cintas Corporation	ANDA	Current
42961-203	Xpect Ibuprofen	Ibuprofen	Cintas Corporation	ANDA	Current
42961-203	Xpect Ibuprofen	Ibuprofen	Cintas Corporation	ANDA	Current
44224-0018	Easy Care First Aid Ibuprofen	Ibuprofen	Tender Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current