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 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