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 43 .
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 · 43 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 2026-09-14 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…2022-10-28 04:53 UTC 2022-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…
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 · 49 matching rows.
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 1 of 5 · 361 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0291 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0291 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0291 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0291 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0291 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0291 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0292 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0292 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0292 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0292 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0292 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0404-0017 Henry Schein Ibuprofen Ibuprofen Henry Schein Inc. ANDA Current 0536-1088 Ibuprofen Ibuprofen Rugby Laboratories ANDA Current 0536-1088 Ibuprofen Ibuprofen Rugby Laboratories ANDA Current 0536-1089 Ibuprofen Ibuprofen Rugby Laboratories ANDA Current 0536-1089 Ibuprofen Ibuprofen Rugby Laboratories ANDA Current 0536-1089 Ibuprofen Ibuprofen Rugby Laboratories ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0075 Physicians Care Ibuprofen Ibuprofen 200mg Acme United Corporation ANDA Current 0924-0275 First Aid Only Ibuprofen Ibuprofen Acme United Corporation ANDA Current 0924-0275 First Aid Only Ibuprofen Ibuprofen Acme United Corporation ANDA Current 11822-0291 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0291 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0291 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0291 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0291 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0291 Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0292 Pain Relief Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 15127-312 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 15127-312 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 15127-335 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 15127-335 Ibuprofen Ibuprofen L&R Distributors, Inc. ANDA Current 16103-407 Ibuprofen Ibuprofen Pharbest Pharmaceuticals, Inc. ANDA Current 21130-292 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-921 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-921 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-921 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-921 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 21130-921 Ibuprofen Ibuprofen Better Living Brands, LLC ANDA Current 29485-8152 24/7 Life IBUPROFEN IBUPROFEN Mechanical Servants, LLC ANDA Current 29485-9291 IBUPROFEN IBUPROFEN 200MG Mechanical Servants LLC ANDA Current 33992-0291 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0291 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 33992-0291 Ibuprofen Ibuprofen GREENBRIER INTERNATIONAL, INC. ANDA Current 36800-292 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-292 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-292 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-292 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-292 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 36800-292 Ibuprofen Ibuprofen Topco Associates, LLC ANDA Current 37205-670 Ibuprofen Ibuprofen CARDINAL HEALTH ANDA Current 37205-670 Ibuprofen Ibuprofen CARDINAL HEALTH ANDA Current 37808-921 Ibuprofen Ibuprofen H E B ANDA Current 37808-921 Ibuprofen Ibuprofen H E B ANDA Current 37808-921 Ibuprofen Ibuprofen H E B ANDA Current 37808-921 Ibuprofen Ibuprofen H E B ANDA Current 37808-921 Ibuprofen Ibuprofen H E B ANDA Current 37808-921 Ibuprofen Ibuprofen H E B ANDA Current 37808-922 Ibuprofen Ibuprofen H E B ANDA Current 37808-922 Ibuprofen Ibuprofen H E B ANDA Current 37808-922 Ibuprofen Ibuprofen H E B 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