Home Applications 075995 Application 075995
Type ANDA
Sponsor PERRIGO 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 A075995-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2002-03-14
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 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075995-001 IBUPROFEN 200MG TABLET / ORAL 2002-03-14 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 26 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Topcare Childrens Ibuprofen IBUPROFEN Topco Associates LLC 45255d2f-c592-4750-abb5-21647d4fbd51 2025-06-10 Warnings Name fallback generic name: IBUPROFEN ibuprofen childrens IBUPROFEN Meijer Distribution Inc 625226ef-d55b-4f93-ad1e-4fe2b07d4133 2025-06-10 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Trifecta Pharmaceuticals USA LLC 37299475-e2f3-de26-e063-6394a90ad62d 2025-06-09 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NCS HealthCare of KY, LLC dba Vangard Labs ab11e142-9e11-4ce4-9671-7e4fe53ffe92 2025-06-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NCS HealthCare of KY, LLC dba Vangard Labs f1842893-7a34-4f77-8231-55fb0c98b22b 2025-06-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN WALGREENS 7653b33c-7489-10db-e053-2991aa0ab508 2025-06-06 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN AMAZON BASIC CARE IBUPROFEN IBUPROFEN Amazon.com Services LLC 113dd693-6abe-1a0f-e063-6394a90a167e 2025-06-06 Warnings Name fallback generic name: IBUPROFEN basic care childrens ibuprofen IBUPROFEN Amazon.com Services LLC 9eafb61a-43bc-4845-b45a-72c7d5ac424e 2025-06-05 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200 IBUPROFEN Walgreen Company 62e8db95-aaef-4b0e-841e-64a0339f3190 2025-06-04 Warnings Name fallback generic name: IBUPROFEN Good Sense Ibuprofen Childrens IBUPROFEN L. Perrigo Company 321d6b3a-3dff-4334-b6ee-6ac801b9907c 2025-06-03 Warnings Name fallback generic name: IBUPROFEN Leader Childrens Ibuprofen IBUPROFEN Cardinal Health 110, LLC. dba Leader 2b0c3bb1-7667-403f-99e6-13c83755b1b5 2025-06-03 Warnings Name fallback generic name: IBUPROFEN care one ibuprofen IBUPROFEN American Sales Company 006adf23-21ab-4a4e-aae9-c4e587777165 2025-06-03 Warnings Name fallback generic name: IBUPROFEN up and up childrens ibuprofen IBUPROFEN Target Corporation 834b7f5e-e636-4537-9bae-2d309fcc8eb3 2025-06-02 Warnings Name fallback generic name: IBUPROFEN equate ibuprofen childrens IBUPROFEN Wal-Mart Stores Inc ed9ee7b5-2d9a-4aaf-a245-aa13fcc6365a 2025-05-23 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Bryant Ranch Prepack 92878aad-0bf9-4303-a1f8-4b9b23848a71 2025-05-21 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 2c3f8149-9b77-54cd-e063-6394a90a847e 2025-05-21 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen IBUPROFEN CVS Pharmacy 884d51d8-4774-4dde-b854-32abfb4b712d 2025-05-20 Warnings Name fallback generic name: IBUPROFEN Ibuprofen minis IBUPROFEN P & L Development, LLC 18b79fc5-57c8-46f1-81f3-2f9e189cdbcb 2025-05-16 Warnings Name fallback generic name: IBUPROFEN dg health ibuprofen IBUPROFEN Dolgencorp, LLC d6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f59 2025-05-15 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. a60a6301-60b7-4f31-9ebe-872ccd8e9e76 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 31058 ORIG 2003-04-10