Home Applications 075139 Application 075139
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 A075139-001 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 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075139-001 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 2 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Better Living Brands, LLC 45520969-7a2d-4469-ba25-7db160d50ccf 2026-07-06 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 21130-393 Ibuprofen IBUPROFEN L.N.K. International, Inc. 027ded51-aa01-6619-3938-c8162a421cf3 2026-06-18 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 110, LLC. DBA Leader a41a0bc2-ef7a-44cd-a42e-aefab41323cc 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN ARMY AND AIR FORCE EXCHANGE SERVICE 01f8fe3a-8810-4b38-8860-d95e05d37709 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 107, LLC 260f5862-d65d-4c34-bf53-26ca30806a67 2026-05-19 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution, Inc. 3e3a5366-535d-45fb-81af-c7d98ac20b11 2026-05-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN CVS Pharmacy 00653b7c-7099-487e-9a01-e89781c21323 2026-04-29 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution Inc 36f7227d-f3cb-44b7-a4c1-27611cd15052 2026-04-24 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 41250-993 Ibuprofen IBUPROFEN Rite Aid Corporation 72e11f2d-a348-4c12-9cd8-1e6f0f6f7399 2026-04-09 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 11822-0393 Ibuprofen Dye-Free IBUPROFEN Wal-Mart Stores Inc 23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6 2026-04-01 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN WALMART INC. 2b04d255-a1df-4698-9b5a-ad7a12205e1b 2026-03-25 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 pain relief ibuprofen IBUPROFEN Rite Aid Corporation 2bd1438e-27b1-81ff-f8e1-0f5b50b04581 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 11822-0392 Ibuprofen IBUPROFEN H E B 88c7486b-f9a7-4856-a25a-7c06e1382f1a 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 37808-393 Ibuprofen IBUPROFEN L.N.K. International, Inc. 82e907e6-86a9-5c7f-93bd-a6319d74100f 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 8ebe3e16-b7ae-d333-6671-5bc935e25900 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. c93da67f-f42e-4baa-976b-73c71ba6dd71 2026-01-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Major Pharmaceuticals 6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6 2025-12-17 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 0904-7914 Dye Free Ibuprofen IBUPROFEN Walgreen Company d3d093f9-207a-40d4-a7be-c6b5a544a0a7 2025-12-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 0363-0438 Ibuprofen IBUPROFEN Family Dollar Services Inc 89ed9311-2185-4660-b219-9ea67b1a71ec 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Topco Associates, LLC bcf7d4c1-1f99-48df-8f74-9abeefa8d41d 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 36800-993
NDC Listings For This Application# NDC listings for this application page 1 of 3 · 210 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0392 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0392 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0392 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0392 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0392 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0393 Ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 0363-0438 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0438 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0438 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0438 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4380 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4380 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4381 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4381 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4381 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4381 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-4381 Dye Free Ibuprofen Ibuprofen Walgreen Company ANDA Current 0904-7914 Ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 0904-7914 Ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 0904-7914 Ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 0904-7914 Ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 0904-7914 Ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 0904-7914 Ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 11822-0392 pain relief ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0392 pain relief ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0392 pain relief ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0392 pain relief ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0392 pain relief ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0393 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0393 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0393 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0393 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 15127-905 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 15127-905 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 15127-907 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 21130-392 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-392 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-392 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-392 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-392 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-393 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-393 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-393 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-393 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-393 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-393 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 33992-0393 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0393 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0393 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0393 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0393 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0393 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 36800-993 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-993 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-993 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-993 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-993 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-993 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 37808-393 Ibuprofen Ibuprofen H E B ANDA Current 37808-393 Ibuprofen Ibuprofen H E B ANDA Current 37808-393 Ibuprofen Ibuprofen H E B ANDA Current 37808-393 Ibuprofen Ibuprofen H E B ANDA Current 41163-392 Ibuprofen Ibuprofen SUPERVALU INC. ANDA Current 41163-392 Ibuprofen Ibuprofen SUPERVALU INC. ANDA Current 41163-392 Ibuprofen Ibuprofen SUPERVALU INC. ANDA Current 41163-393 Ibuprofen Ibuprofen SUPERVALU INC. ANDA Current 41163-393 Ibuprofen Ibuprofen SUPERVALU INC. ANDA Current 41250-993 Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-993 Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-993 Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-993 Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-993 Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-993 Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 49035-393 Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42949 SUPPL 2007-07-27 42948 SUPPL 2007-07-27 42947 SUPPL 2007-07-27 22429 SUPPL 2007-07-27 42946 SUPPL 2007-07-24 42945 SUPPL 2007-07-24 22428 SUPPL 2007-07-24 22427 SUPPL 2007-07-24 22426 ORIG 2007-07-24 30771 ORIG 1999-03-01