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 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
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 · 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	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c2088c7a36db…`
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…`

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 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 51013-319
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 2 of 4 · 268 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
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
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-718	Medi-First Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-783	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-783	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-783	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-783	Medique at Home Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
49035-248	Ibuprofen	Ibuprofen	EQUATE (Walmart Stores, Inc.)	ANDA	Current
49035-248	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-661	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-661	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-661	Ibuprofen	Ibuprofen	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49314-1003	Unishield Ibuprofen	Ibuprofen	Unishield	ANDA	Current
49314-1003	Unishield Ibuprofen	Ibuprofen	Unishield	ANDA	Current
49314-1003	Unishield Ibuprofen	Ibuprofen	Unishield	ANDA	Current
50804-167	Ibuprofen	Ibuprofen	Good Sense (Geiss, Destin & Dunn, Inc.)	ANDA	Current
50804-167	Ibuprofen	Ibuprofen	Geiss, Destin & Dunn, Inc (Goodsense)	ANDA	Current
50804-217	Ibuprofen	Ibuprofen	Good Sense (Geiss, Destin & Dunn, Inc.)	ANDA	Current
50804-217	Ibuprofen	Ibuprofen	Good Sense (Geiss, Destin & Dunn, Inc.)	ANDA	Current
50844-269	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-269	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-269	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-269	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
51013-319	Ibuprofen	Ibuprofen	PuraCap Pharmaceutical LLC	ANDA	Current
53329-673	Ibuprofen	Ibuprofen	Medline Industries	ANDA	Current
53329-673	Ibuprofen	Ibuprofen	Medline Industries	ANDA	Current
53329-674	Ibuprofen	Ibuprofen	Medline industries, Inc.	ANDA	Current
53329-674	Ibuprofen	Ibuprofen	Medline industries, Inc.	ANDA	Current
53329-674	Ibuprofen	Ibuprofen	Medline industries, LP	ANDA	Current
53329-674	Ibuprofen	Ibuprofen	Medline industries, LP	ANDA	Current
55312-216	Ibuprofen	Ibuprofen	Western Family Foods, Inc.	ANDA	Current
55312-218	Ibuprofen	Ibuprofen	Western Family Foods, Inc.	ANDA	Current
55312-219	Ibuprofen	Ibuprofen	Western Family Foods, Inc.	ANDA	Current
55312-248	Ibuprofen	Ibuprofen	Western Family Foods, Inc.	ANDA	Current
55316-249	Ibuprofen	Ibuprofen	Healthy Accents (DZA Brands, LLC)	ANDA	Current
55316-249	Ibuprofen	Ibuprofen	Healthy Accents (DZA Brands, LLC)	ANDA	Current
55319-248	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-248	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-396	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-396	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-396	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-397	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-397	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-397	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-568	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-568	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-568	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-661	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-661	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-661	Ibuprofen	Ibuprofen	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55670-850	MoreBrand Ibuprofen	Ibuprofen	Moore Medical	ANDA	Current
55670-850	MoreBrand Ibuprofen	Ibuprofen	Moore Medical	ANDA	Current
55670-850	MoreBrand Ibuprofen	Ibuprofen	Moore Medical	ANDA	Current
55670-850	MoreBrand Ibuprofen	Ibuprofen	Moore Medical	ANDA	Current
55670-850	MoreBrand Ibuprofen	Ibuprofen	Moore Medical	ANDA	Current
55670-850	MoreBrand Ibuprofen	Ibuprofen	Moore Medical	ANDA	Current
55681-401	Ibuprofen	Ibuprofen	TWIN MED LLC	ANDA	Current
55910-768	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-768	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-768	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-768	Ibuprofen	Ibuprofen	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-847	Ibuprofen	Ibuprofen	Dolgencorp, Inc.	ANDA	Current
55910-847	Ibuprofen	Ibuprofen	Dolgencorp, Inc.	ANDA	Current
55910-847	Ibuprofen	Ibuprofen	Dolgencorp, Inc.	ANDA	Current
55910-847	Ibuprofen	Ibuprofen	Dolgencorp, Inc.	ANDA	Current
59726-117	Pain Relief	Ibuprofen	P and L Development of New York Corporation	ANDA	Current
59726-248	Pain Relief	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-249	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current