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 3 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	AMERIFOODS TRADING COMPANY	f6dc2a73-046b-6b93-e053-6294a90ab295	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	7b2f7a68-8f5e-a340-e053-2991aa0a5aeb	2025-07-01	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN	IBUPROFEN	AAA Pharmaceutical, Inc.	1e686091-6456-36c8-e063-6294a90a3866	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	FSA STORE INC.	ec6b015d-e72e-89c4-e053-2a95a90af81c	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	47434f23-5ac9-4cb4-a963-7c8bf9e06361	2025-06-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	3b0e4ccc-cc0b-42fb-9163-7560740d9592	2025-06-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Redicare Ibuprofen 200mg	IBUPROFEN 200MG	Redicare LLC	2f0db953-33e2-1729-e063-6294a90af074	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen, Caseys 4good	IBUPROFEN TABLETS	Lil' Drug Store Products, Inc.	04b3ad8b-bdf9-47f3-e063-6294a90ac350	2024-12-31	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	59c77fd3-5e67-45ec-82ad-44585390c4f3	2024-12-30	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	a96d012e-b132-4e99-b84b-ccd3a9a05cbb	2024-12-30	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Cabinet Pain Reliever and Fever Reducer	IBUPROFEN	Spirit Pharmaceutical LLC	e172a8d8-779d-4ad9-b6b0-08a198a58034	2024-12-30	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af	2024-12-20	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Dolgencorp, Inc.	5398f5b7-a9a6-4f7e-a06c-e524b9939562	2024-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 55910-847
Ibuprofen	IBUPROFEN	Spirit Pharmaceuticals LLC	e38d23e5-b455-41b5-86f6-c318b17bd345	2024-12-13	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Winco Foods, LLC	428b011f-d7d3-4a3b-87dd-d4e84e90cabd	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Winco Foods, LLC	60130bdc-6f45-4998-b53a-cad6cbf25036	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Granules India Limited	fd01353d-1d1d-42b5-9a03-575052189bf5	2024-08-13	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
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
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

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