Home Applications 202312 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 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 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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A202312-001 IBUPROFEN 200MG TABLET / ORAL 2016-10-07 84e616aacf4f…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…
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 2 of 2 · 33 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 8fed1f86-49a0-4747-e053-2a95a90a42b8 2025-07-01 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 41163-312 Ibuprofen IBUPROFEN AAA Pharmaceutical, Inc. 78cf5df8-392b-4a4e-b424-af765a6defdf 2025-06-17 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 57344-811 Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. a60a6301-60b7-4f31-9ebe-872ccd8e9e76 2025-05-15 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. 32f86bfb-67a6-49b5-a90a-5197f0d1baba 2025-05-15 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 Ibuprofen IBUPROFEN DISCOUNT DRUG MART 9998b851-825b-a97d-e053-2a95a90affc6 2025-05-15 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 53943-111 Ibuprofen IBUPROFEN DISCOUNT DRUG MART 999902da-4850-68ab-e053-2a95a90a82ea 2025-05-15 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 53943-112 Assured Ibuprofen IBUPROFEN Spirit Pharmaceuticals LLC 119263b5-c3b7-46dc-a3bd-9893bfd24628 2024-12-10 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 68210-4139 Ibuprofen IBUPROFEN BETTER LIVING BRANDS LLC. a3fadcc0-97f5-9f9b-e053-2a95a90aeb54 2023-03-15 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 21130-359 Ibuprofen IBUPROFEN TOPCO ASSOCIATES LLC cef74c2f-0c23-609d-e053-2a95a90a6b8e 2022-11-23 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 36800-286 Ibuprofen IB IBUPROFEN WINCO FOODS, LLC 9d78644d-83c7-46d1-8156-0d76acb7c299 2020-09-17 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 67091-368 Ibuprofen IB IBUPROFEN WINCO FOODS, LLC ee867519-227f-44ba-ba8b-2dbefcc9fc67 2020-09-17 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 67091-369 Ibuprofen 200mg IBUPROFEN 200MG Athlete's Needs, Inc. 2db10105-6fd3-420d-8889-7cfd6f396e5f 2017-11-14 Warnings Exact identifier application applno (ANDA): 202312 application number: ANDA202312 ndc (product): 53185-381
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 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