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 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 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 Uline Ibuprofen IBUPROFEN Uline d7342a15-9d49-74ed-e053-2a95a90a22cc 2025-09-09 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 69790-609 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 ndc (product): 73408-509 Ibuprofen IBUPROFEN Sam's West Inc 6293a134-860d-4d12-9e4b-28490f824108 2025-09-03 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 68196-291 Ibuprofen IBUPROFEN Chain Drug Consortium 6c593a9c-680e-4645-8e8f-d8d044c92ca1 2025-07-18 Warnings Exact identifier application applno (ANDA): 075010 application number: ANDA075010 ndc (product): 68016-634 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 5 of 5 · 361 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66715-5839 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-5839 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-5839 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-9739 Lil Drug Store Ibuprofen Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9739 Lil Drug Store Ibuprofen Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9739 Lil Drug Store Ibuprofen Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9739 Lil Drug Store Ibuprofen Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9819 Ibuprofen Ibuprofen tablet, film-coated Lil' Drug Store Products, Inc. ANDA Current 67751-164 Handy Solutions Ibuprofen IBUPROFEN Navajo Manufacturing Company Inc. ANDA Current 67751-164 Handy Solutions Ibuprofen IBUPROFEN Navajo Manufacturing Company Inc. ANDA Current 68016-634 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-634 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-634 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-634 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-645 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-645 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-645 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-645 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-645 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68196-291 Ibuprofen Ibuprofen Sam's West Inc ANDA Current 68599-8050 Ibuprofen Ibuprofen Tablets McKesson ANDA Current 68599-8050 Ibuprofen Ibuprofen Tablets McKesson ANDA Current 68788-7156 Ibuprofen ibuprofen Preferred Pharmaceuticals Inc. ANDA Current 68788-7156 Ibuprofen ibuprofen Preferred Pharmaceuticals Inc. ANDA Current 69790-609 Uline Ibuprofen Ibuprofen Uline ANDA Current 69790-609 Uline Ibuprofen Ibuprofen Uline ANDA Current 69842-891 Ibuprofen Ibuprofen CVS Pharmacy ANDA Current 69842-891 Ibuprofen Ibuprofen CVS PHARMACY ANDA Current 69842-891 Ibuprofen Ibuprofen CVS Pharmacy ANDA Current 69842-891 Ibuprofen Ibuprofen CVS PHARMACY ANDA Current 70518-3372 Ibuprofen ibuprofen REMEDYREPACK INC. ANDA Current 70729-291 Ibuprofen ibuprofen Breeden Brothers, LLC ANDA Current 73408-509 Ibuprofen Thompson Ibuprofen Thompson Safety ANDA Current 73408-509 Ibuprofen Thompson Ibuprofen Thompson Safety ANDA Current 73408-509 Ibuprofen Thompson Ibuprofen Thompson Safety ANDA Current 73408-609 Crane Safety Ibuprofen Ibuprofen Crane Safety, LLC ANDA Current 73408-609 Crane Safety Ibuprofen Ibuprofen Crane Safety, LLC ANDA Current 73408-609 Crane Safety Ibuprofen Ibuprofen Crane Safety, LLC ANDA Current 73408-609 Crane Safety Ibuprofen Ibuprofen Crane Safety, LLC ANDA Current 73408-609 Crane Safety Ibuprofen Ibuprofen Crane Safety, LLC ANDA Current 76413-345 Ibuprofen Ibuprofen Central Texas Community Health Centers 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