Home Applications 073691 Application 073691
Type ANDA
Sponsor CONTRACT PHARMACAL 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 A073691-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1994-02-25
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 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073691-001 IBUPROFEN 200MG TABLET / ORAL 1994-02-25 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 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN REMEDYREPACK INC. 2572ed69-d5a7-4513-a202-aca3230e7ec5 2026-07-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 8abd74a4-ad33-4c10-b677-acb469f815e6 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Amneal Pharmaceuticals LLC 17577b3b-e755-45d1-8b53-775d058578b2 2026-07-29 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NUVICARE LLC b063d2dc-d579-46e7-8cfc-1596c803c7f9 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN Amazon.com Services LLC b5a47efe-222f-4cbd-b649-caafd16a0829 2026-07-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN Harris Teeter 637210f0-6494-4656-8b2b-14d7476cb127 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN Harris Teeter 9d5c994a-8363-4ddb-956c-e12b79a32a58 2026-07-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN Harris Teeter 87ffbf01-54de-45a8-b2a3-367d21927882 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN Harris Teeter 14515409-736f-4119-b6a0-cb19ee2e948e 2026-07-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN Harris Teeter 1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ADVIL MIGRAINE IBUPROFEN Haleon US Holdings LLC e4a6219d-4ad4-0119-4cf8-7fc39b4b5979 2026-07-29 Warnings Name fallback generic name: IBUPROFEN Advil IBUPROFEN Haleon US Holdings LLC 1f01c10a-9434-91a4-2ee4-352315a6b610 2026-07-29 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 291602fa-8ebe-4200-bba7-9798c90f8a50 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NUVICARE LLC 7905edc1-2a45-4adc-a7bc-42b1ddb6ba59 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN H E B 21567c0f-abba-4a40-a0b9-5ce49b3d9648 2026-07-28 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PD-Rx Pharmaceuticals, Inc. 656658cc-8cf0-42b6-af4f-4e3ab7648625 2026-07-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN REMEDYREPACK INC. a7756b22-73cf-4262-aa8e-0577ddecd03b 2026-07-24 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Shield Pharmaceuticals Corp 1ca722bb-940e-4b3e-9561-d87e2feb1ff8 2026-07-24 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Shield Pharmaceuticals Corp fc6c29b4-f1b3-4cfe-8c96-564d083be39c 2026-07-24 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Rite Aid Corporation 26bccfc1-bc8d-4241-a078-c760048951c9 2026-07-24 Warnings Name fallback generic name: IBUPROFEN