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 27 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. 32f86bfb-67a6-49b5-a90a-5197f0d1baba 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN DISCOUNT DRUG MART 9998b851-825b-a97d-e053-2a95a90affc6 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN DISCOUNT DRUG MART 999902da-4850-68ab-e053-2a95a90a82ea 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 3520deb7-5e45-3d0f-e063-6394a90ab44b 2025-05-14 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN profen ib IBUPROFEN Publix Super Markets Inc 51fbfd25-3c4d-4de1-8fa2-e5b4b24022f2 2025-05-13 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN ATLANTIC BIOLOGICALS CORP. 230914e6-fe0c-45be-8b2e-e066c71d004c 2025-05-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN good sense ibuprofen childrens IBUPROFEN L. Perrigo Company b8e3ad4f-3212-4674-bcdf-a60a6b23d7bb 2025-05-12 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Meijer Distribution Inc 3b15dc44-ae1d-43c6-b6c5-05fa31beb554 2025-05-12 Warnings Name fallback generic name: IBUPROFEN Up and Up childrens ibuprofen IBUPROFEN Target Corporation 28911692-882b-4e30-ba1d-5c10f847be80 2025-05-12 Warnings Name fallback generic name: IBUPROFEN Equaline Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI c611afc0-5cde-4f01-908a-de52cb61ab02 2025-05-08 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN AAFES/Your Military Exchanges 773b0230-a3a3-44e0-a22b-d143796ca365 2025-05-08 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Equaline ibuprofen childrens IBUPROFEN United Natural Foods, Inc. dba UNFI 811d4360-7468-4ef8-a60e-6e9a6e169de0 2025-05-08 Warnings Name fallback generic name: IBUPROFEN Good Sense Childrens Ibuprofen IBUPROFEN L. Perrigo Company a8fc1b0c-dd69-4567-8eea-de4d9b0c7740 2025-05-07 Warnings Name fallback generic name: IBUPROFEN foster and thrive childrens ibuprofen ib IBUPROFEN Strategic Sourcing Services LLC 37adf659-9a92-428b-ac99-5718f242a4e9 2025-05-07 Warnings Name fallback generic name: IBUPROFEN up and up ibuprofen IBUPROFEN Target Corporation 6e0330ac-a111-4574-9197-d7aab33b8608 2025-05-07 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Meijer Distribution Inc 66b19ed1-6cf9-4705-82cd-02f23c6379e7 2025-05-06 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN equaline ibuprofen childrens IBUPROFEN United Natural Foods, Inc. dba UNFI 835c3bc8-fb55-4b7e-98ad-3d84d089c8cb 2025-05-06 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 34673d3b-41cd-f4c9-e063-6394a90a8510 2025-05-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 3467b45b-c432-2923-e063-6394a90a1044 2025-05-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN Major Pharmaceuticals b4962985-47e6-4389-874f-76742b086e2f 2025-05-03 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