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 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 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 · 44 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 2026-10-15 13:18:30 2026-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 caaa826d4ba7…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…
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 3 · 48 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN L.N.K. International, Inc. d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c 2026-01-12 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 50844-292 Ibuprofen IBUPROFEN Meijer Distribution Inc c0c64ba5-b6b0-4221-9e44-110d92c93782 2026-01-12 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN DOLGENCORP, LLC 37ccb303-c70e-48b3-a8a3-2b0097cf8f88 2026-01-05 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Northwind Health Company, LLC ab313564-27dc-0297-e053-2a95a90a6690 2026-01-01 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 51655-354 Ibuprofen 24/7 Life by 7-Eleven IBUPROFEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 45b3b825-dab7-3328-e063-6294a90a7d2a 2025-12-11 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Physicians Care Ibuprofen IBUPROFEN 200MG Acme United Corporation 490c1109-dad7-4135-e054-00144ff8d46c 2025-10-31 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION INC 6521bc47-4d9c-4a5b-b109-3841f3be4b6c 2025-10-07 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Green Guard Ibupro relief IBUPROFEN Unifirst First Aid Corporation 2923c4a3-f994-67a7-e054-00144ff8d46c 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Medique Iprin IBUPROFEN Unifirst First Aid Corporation 2910b50b-c8de-382b-e054-00144ff88e88 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Medique at Home Iprin IBUPROFEN Unifirst First Aid Corporation b5547f33-2a81-867d-e053-2995a90aa2d0 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Direct Safety Ibuprofen IBUPROFEN Conney Safety Products, LLC 28d45743-d298-29db-e054-00144ff8d46c 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Unishield Ibuprofen IBUPROFEN Unishield b9e2e2ba-e2ad-eace-e053-2995a90aed35 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 49314-0993 Uline Ibuprofen IBUPROFEN Uline d7342a15-9d49-74ed-e053-2a95a90a22cc 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Henry Schein Ibuprofen IBUPROFEN Henry Schein Inc. 267c7c8a-2f3f-1f4d-e054-00144ff8d46c 2025-09-08 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen Thompson IBUPROFEN Thompson Safety ccfbc048-f666-3188-e053-2995a90ae08f 2025-09-08 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Sam's West Inc 6293a134-860d-4d12-9e4b-28490f824108 2025-09-03 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Chain Drug Consortium 6c593a9c-680e-4645-8e8f-d8d044c92ca1 2025-07-18 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN Wildman Business Group 9e71f1c1-5272-4209-8974-6c525b141155 2024-08-19 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 3e3848f2-4922-39ea-e054-00144ff88e88 2024-06-25 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 IBUPROFEN IBUPROFEN 200MG Lil' Drug Store Products, Inc. 8fc65767-1783-4f7f-8680-9e43ba4d5481 2024-06-19 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010
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 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