Home Applications 075010 Application 075010
Type ANDA
Sponsor LNK 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 1 .
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 A075010-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1999-03-01
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 cb3db0bc1861…
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 3 · 53 matching rows.
NDC Listings For This Application# NDC listings for this application page 3 of 5 · 361 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49035-912 Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-912 Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-912 Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-912 Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-912 Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49314-0993 Unishield Ibuprofen Ibuprofen Unishield ANDA Current 49314-0993 Unishield Ibuprofen Ibuprofen Unishield ANDA Current 49314-0993 Unishield Ibuprofen Ibuprofen Unishield ANDA Current 50066-374 Dragon Ibuprofen 200 mg Genomma Lab USA ANDA Current 50090-3977 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50090-3977 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50090-3978 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50090-4693 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50090-4694 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50090-5020 Ibuprofen ibuprofen A-S Medication Solutions ANDA Current 50844-257 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-257 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-257 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-257 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-291 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-291 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-291 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-291 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-291 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-291 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-292 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-292 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-292 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-292 Ibuprofen ibuprofen L.N.K. International, Inc ANDA Current 50844-292 Ibuprofen ibuprofen L.N.K. International, Inc. ANDA Current 50844-921 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-921 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-921 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-921 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-921 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 50844-921 Ibuprofen Ibuprofen L.N.K. International, Inc. ANDA Current 51655-354 Ibuprofen ibuprofen Northwind Pharmaceuticals ANDA Current 51655-354 Ibuprofen ibuprofen Northwind Pharmaceuticals ANDA Current 52124-0009 Ibuprofen IBUPROFEN Genuine First Aid LLC ANDA Current 53943-291 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-291 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-291 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-291 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-291 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-292 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-292 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-292 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-292 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 53943-292 Ibuprofen Ibuprofen Discount Drug Mart ANDA Current 54162-941 Ibuprofen Ibuprofen Geritrex LLC ANDA Current 55301-291 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-291 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-291 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-291 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-291 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-292 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-292 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-292 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-292 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-292 Ibuprofen Ibuprofen ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55315-291 Ibuprofen Ibuprofen FRED'S, INC. ANDA Current 55315-291 Ibuprofen Ibuprofen FRED'S, INC. ANDA Current 55315-291 Ibuprofen Ibuprofen FRED'S, INC. ANDA Current 55315-292 Ibuprofen Ibuprofen FRED'S, INC. ANDA Current 55315-292 Ibuprofen Ibuprofen FRED'S, INC. ANDA Current 55315-292 Ibuprofen Ibuprofen FRED'S, INC. ANDA Current 55319-291 Ibuprofen Ibuprofen Family Dollar Services Inc ANDA Current 55670-805 moorebrand Ibuprofen I buprofen 200 mg Moore Medical LLC ANDA Current 55670-805 moorebrand Ibuprofen I buprofen 200 mg Moore Medical LLC ANDA Current 55670-805 moorebrand Ibuprofen I buprofen 200 mg Moore Medical LLC ANDA Current 55670-805 moorebrand Ibuprofen I buprofen 200 mg Moore Medical LLC ANDA Current 55670-805 moorebrand Ibuprofen I buprofen 200 mg Moore Medical LLC ANDA Current 57243-291 Ibuprofen Ibuprofen Salado Sales, Inc. ANDA Current 57243-291 Ibuprofen Ibuprofen Salado Sales, Inc. ANDA Current 57243-291 Ibuprofen Ibuprofen Salado Sales, Inc. ANDA Current 57243-291 Ibuprofen Ibuprofen Salado Sales, Inc. ANDA Current 57243-291 Ibuprofen Ibuprofen Salado Sales, Inc. ANDA Current 57896-941 Ibuprofen ibuprofen Geri-Care Pharmaceutical Corp ANDA Current 57896-941 Ibuprofen ibuprofen Geri-Care Pharmaceutical Corp ANDA Current 57896-941 Ibuprofen ibuprofen Geri-Care Pharmaceutical Corp ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42919 SUPPL 2007-07-20 42918 SUPPL 2007-07-20 42917 SUPPL 2007-07-20 42916 ORIG 2007-07-20 8488 ORIG 1999-03-01