Application 202312

Type: ANDA
Sponsor: GRANULES INDIA LTD

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
A202312-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2016-10-07

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	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`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 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	22102461-0196-4ef0-aef4-66997d74d118	2026-08-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Harris Teeter	637210f0-6494-4656-8b2b-14d7476cb127	2026-07-29	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 72036-212
IBUPROFEN	IBUPROFEN	Harris Teeter	14515409-736f-4119-b6a0-cb19ee2e948e	2026-07-29	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 72036-211
IBUPROFEN	IBUPROFEN	Granules India Limited	97516b9f-219a-429d-850d-1fe9fd66646b	2026-06-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 62207-320 ndc (product): 62207-321
Ibuprofen	IBUPROFEN	HYVEE INC	459fc063-0664-09b7-e063-6394a90a89e0	2026-01-13	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	HYVEE INC	459fc670-32a3-61a6-e063-6294a90aea5a	2026-01-13	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a568fd1e-9bf0-3c03-e053-2a95a90a45b7	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 72476-358
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	1a00c85b-2ba5-32c3-e063-6294a90af148	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Walgreens	07edb8d0-2fa8-4b40-e063-6294a90a2fe9	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	a3c1a61b-88fc-419c-e053-2a95a90ac0c3	2025-12-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 21130-358
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	a42f96c4-322d-4714-9435-7b5a4e8b6ae5	2025-12-11	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 63941-111
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	36b95840-f621-437a-bf49-406d320964da	2025-12-11	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 63941-301
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1ded4e-1d3b-1ab6-e053-2995a90aa80d	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 63868-570
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1cc205-b9e3-03fc-e053-2995a90aaffb	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 63868-571
IBUPROFEN	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f40f5-625d-3f2e-e053-2a95a90a438b	2025-11-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 72476-112
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f42a7-c2d8-4a51-e053-2a95a90a1677	2025-11-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 72476-111
Ibuprofen	IBUPROFEN	Demoulas Super Markets, Inc	39802e26-1028-d2fe-e063-6394a90a24c7	2025-07-16	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	9714e804-fadb-103d-e053-2a95a90ad765	2025-07-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 68998-011
Ibuprofen	IBUPROFEN	MARC GLASSMAN, INC.	9714de6b-068b-d6b9-e053-2995a90a3b27	2025-07-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 68998-012
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fecb3a8-d288-cacf-e053-2a95a90ae238	2025-07-01	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 41163-116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21130-358	Ibuprofen	Ibuprofen	BETTER LIVING BRANDS LLC.	ANDA	Current
21130-358	Ibuprofen	Ibuprofen	BETTER LIVING BRANDS LLC.	ANDA	Current
21130-359	Ibuprofen	Ibuprofen	BETTER LIVING BRANDS LLC.	ANDA	Current
36800-286	Ibuprofen	Ibuprofen	TOPCO ASSOCIATES LLC	ANDA	Current
41163-116	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
41163-312	ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
49035-684	equate ibuprofen	ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-684	equate ibuprofen	ibuprofen	Wal-Mart Stores Inc	ANDA	Current
53185-381	Ibuprofen 200mg	Ibuprofen 200mg	Athlete's Needs, Inc.	ANDA	Current
53185-381	Ibuprofen 200mg	Ibuprofen 200mg	Athlete's Needs, Inc.	ANDA	Current
53185-381	Ibuprofen 200mg	Ibuprofen 200mg	Athlete's Needs, Inc.	ANDA	Current
53943-111	ibuprofen	Ibuprofen	DISCOUNT DRUG MART	ANDA	Current
53943-112	Ibuprofen	Ibuprofen	DISCOUNT DRUG MART	ANDA	Current
55319-358	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-398	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
55319-398	Ibuprofen	Ibuprofen	FAMILY DOLLAR	ANDA	Current
57344-811	Ibuprofen	Ibuprofen	AAA PHARMACEUTICAL, INC.	ANDA	Current
62207-320	IBUPROFEN	IBUPROFEN	Granules India Limited	ANDA	Current
62207-320	IBUPROFEN	IBUPROFEN	Granules India Limited	ANDA	Current
62207-320	IBUPROFEN	IBUPROFEN	Granules India Limited	ANDA	Current
62207-321	IBUPROFEN	IBUPROFEN	Granules India Limited	ANDA	Current
62207-321	IBUPROFEN	IBUPROFEN	Granules India Limited	ANDA	Current
62207-321	IBUPROFEN	IBUPROFEN	Granules India Limited	ANDA	Current
62207-357	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-357	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-357	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-358	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-358	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-358	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
63868-570	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-571	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63941-111	Ibuprofen	Ibuprofen	VALU MERCHANDISERS COMPANY	ANDA	Current
63941-301	Ibuprofen	Ibuprofen	VALU MERCHANDISERS COMPANY	ANDA	Current
67091-368	Ibuprofen IB	Ibuprofen	WINCO FOODS, LLC	ANDA	Current
67091-369	Ibuprofen IB	Ibuprofen	WINCO FOODS, LLC	ANDA	Current
68210-0011	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0011	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0011	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0011	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0011	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4139	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4139	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4139	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68998-011	Ibuprofen	Ibuprofen	MARC GLASSMAN, INC.	ANDA	Current
68998-012	Ibuprofen	Ibuprofen	MARC GLASSMAN, INC.	ANDA	Current
72036-211	Ibuprofen	Ibuprofen	Harris Teeter	ANDA	Current
72036-212	Ibuprofen	Ibuprofen	Harris Teeter	ANDA	Current
72476-111	Ibuprofen	Ibuprofen	RETAIL BUSINESS SERVICES , LLC.	ANDA	Current
72476-112	IBUPROFEN	Ibuprofen	RETAIL BUSINESS SERVICES , LLC.	ANDA	Current
72476-358	Ibuprofen	Ibuprofen	RETAIL BUSINESS SERVICES,LLC.	ANDA	Current