Home Applications 076741 Application 076741
Type ANDA
Sponsor LNK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076741-001 IBUPROFEN IBUPROFEN 100MG TABLET / ORAL 2004-06-17
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 · 42 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 2026-08-18 06:07:40 2026-07 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076741-001 IBUPROFEN 100MG TABLET / ORAL 2004-06-17 e64feba35796…
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 49 · 963 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Infants Ibuprofen IBUPROFEN Walgreens 3bbbe142-a00c-404b-a116-81ad730ea130 2026-08-25 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN PD-Rx Pharmaceuticals, Inc. 3a38add6-a114-4e18-836c-3bfc727db231 2026-08-21 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Safeway, Inc. 57f06daf-690d-44a7-95a5-468732949750 2026-08-19 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. 59554a62-3a9a-c0f3-e063-6294a90ad3fd 2026-08-18 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN CHILDRENS IBUPROFEN IBUPROFEN Amazon.com Services LLC 0865fe8a-df81-4ae4-8bed-29a022ba164f 2026-08-17 Warnings Name fallback generic name: IBUPROFEN CHILDRENS IBUPROFEN IBUPROFEN Amazon.com Services LLC 5ba08c30-7eb9-433b-b763-9288f4dd1012 2026-08-12 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN AiPing Pharmaceutical, Inc. 3e131710-2579-446e-8076-f602ecea813f 2026-08-11 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN INFANTS IBUPROFEN IBUPROFEN Amazon.com Services LLC 8588617a-d4b8-4ab5-8b87-30e6f1121cc3 2026-08-10 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Shield Pharmaceuticals Corp 22102461-0196-4ef0-aef4-66997d74d118 2026-08-10 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen minis IBUPROFEN Walgreens 6d1d131d-0741-4a75-8383-9322f4f3faab 2026-08-06 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Shield Pharmaceuticals Corp 216e5600-56b4-44b0-88b7-69adfb245802 2026-08-06 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Lidl US LLC 0ca02f8b-4413-4e7c-a67b-8c67c53e1343 2026-08-06 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN COSTCO WHOLESALE CORPORATION 4b8ad98e-de76-4f49-3b89-01e9dd5cde16 2026-08-06 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Dye Free Ibuprofen IBUPROFEN Walgreen Company d3d093f9-207a-40d4-a7be-c6b5a544a0a7 2026-08-06 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN P & L Development, LLC 159b68b7-54e5-4f83-b632-f49e7b4b14a5 2026-08-05 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Walgreen Company c118b290-f821-4e73-906e-8a93edaf34e4 2026-08-05 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Dye Free Ibuprofen IBUPROFEN Walgreen Company 8944a0e8-2928-4494-915f-d1e0a6d4bf5c 2026-08-04 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN REMEDYREPACK INC. 560e4e05-21e0-4b2a-ab2f-872b5dbb3901 2026-08-04 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Chain Drug Marketing Association, Inc. 733d0b21-c177-4c60-9243-2f1e7cb5854a 2026-08-04 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 8abd74a4-ad33-4c10-b677-acb469f815e6 2026-08-03 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN