Home Applications 071644 Application 071644
Type ANDA
Sponsor VINTAGE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 400MG 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 A071644-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL 1988-02-01
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 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071644-001 IBUPROFEN 400MG TABLET / ORAL AB 1988-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071644-001 IBUPROFEN 400MG TABLET / ORAL 1988-02-01 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 18 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN RETAIL BUSINESS SERVICES , LLC. 8f9f308f-0ca5-12fa-e053-2995a90a47fc 2025-11-18 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN MOTRIN IB IBUPROFEN R J General Corporation afa87bb5-7fcb-4ccd-acac-f7931242181f 2025-11-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200 mg IBUPROFEN R J General Corporation dd9aaf80-6c2b-41a3-87b9-61642aaed4f0 2025-11-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200 mg IBUPROFEN R J General Corporation 1c18a2da-1718-4c00-aea8-9fb4a3418312 2025-11-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200 mg IBUPROFEN R J General Corporation cd3060a5-3b90-42e4-89cd-3b620859045f 2025-11-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200 mg IBUPROFEN R J General Corporation 1c7221ae-52d1-4d18-b586-c47ff656150d 2025-11-17 Warnings Name fallback generic name: IBUPROFEN good sense ibuprofen IBUPROFEN Preferred Pharmaceuticals Inc. c447fc6b-e9ef-447a-9609-5f893e18dfa7 2025-11-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Family Dollar Services Inc 89ed9311-2185-4660-b219-9ea67b1a71ec 2025-11-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Topco Associates, LLC bcf7d4c1-1f99-48df-8f74-9abeefa8d41d 2025-11-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. d1f20e10-0128-f2e5-1a03-6da5d7288a4e 2025-11-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN ARMY AND AIR FORCE EXCHANGE SERVICE bf7d0929-a7d5-4164-9c24-566eddcd6489 2025-11-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN P & L Development, LLC ce215099-91b0-43fd-8ac9-17fe6508842c 2025-11-11 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) da9d0301-ec14-40c5-b0b9-17096913a849 2025-11-11 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN GOODNOW PAIN RELIEF IBUPROFEN Gobrands, Inc 0759085d-6ac3-446b-ac2c-8dc30e32e1d1 2025-11-08 Warnings Name fallback generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Kroger Company 96c955b1-3139-4b12-b584-83804bc1ca6b 2025-11-03 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. f60445d3-807e-0bbf-e053-2995a90a1299 2025-10-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN KOSHER MEDS IBUPROFEN Mollec Inc c9c31326-6a19-9a9c-e053-2a95a90aed06 2025-10-29 Warnings Name fallback generic name: IBUPROFEN Kosher Meds Dye-Free Ibuprofen IBUPROFEN Mollec Inc ba1a0bc2-0a28-4d73-9667-5a220b806e87 2025-10-29 Warnings Name fallback generic name: IBUPROFEN Up and Up Childrens Ibuprofen IBUPROFEN Target Corporation 17b3ca97-1bd6-4e76-a47f-2e35ef36b707 2025-10-28 Warnings Name fallback generic name: IBUPROFEN childrens ibuprofen 100 IBUPROFEN Walgreen Company 7b798146-393f-422c-87f0-0bf800df0c71 2025-10-28 Warnings Name fallback generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.