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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`e64feba35796…`

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 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	AMERIFOODS TRADING COMPANY	f6dc62db-f728-66fc-e053-6394a90a96b3	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
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 ndc (product): 41163-509
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	IBUPROFEN	Bi-Mart	7ceacd63-d5fa-4cab-b8f3-a5131c97bb90	2025-02-01	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	BI-MART	34440532-03e1-4feb-b3e2-dab869edeb15	2025-02-01	Warnings	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
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

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