Home Applications 077349 Application 077349
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 200MG No Yes
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 A077349-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21
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 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 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 1 of 2 · 21 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 120 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 56062-074 ibuprofen Ibuprofen Publix Super Markets Inc ANDA Current 56062-074 ibuprofen Ibuprofen Publix Super Markets Inc ANDA Current 56062-517 ibuprofen Ibuprofen Publix Super Markets Inc ANDA Current 59779-074 ibuprofen Ibuprofen CVS Pharmacy ANDA Current 59779-074 ibuprofen Ibuprofen CVS Pharmacy ANDA Current 59779-517 Ibuprofen Ibuprofen CVS Pharmacy ANDA Current 59779-517 Ibuprofen Ibuprofen CVS Pharmacy ANDA Current 62011-0213 Health Mart Ibuprofen IB Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0213 Health Mart Ibuprofen IB Ibuprofen McKesson ANDA Current 62011-0213 Health Mart Ibuprofen IB Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0222 Health Mart Ibuprofen IB Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0222 Health Mart Ibuprofen IB Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0222 Health Mart Ibuprofen IB Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0222 Health Mart Ibuprofen IB Ibuprofen McKesson ANDA Current 63981-517 kirkland signature ibuprofen ib Ibuprofen Costco Wholesale Company ANDA Current 63981-517 kirkland signature ibuprofen ib Ibuprofen Costco Wholesale Company ANDA Current 66715-9812 Motrin IB Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9812 Motrin IB Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9812 Motrin IB Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9812 Motrin IB Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9812 Motrin IB Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 66715-9812 Motrin IB Ibuprofen Lil' Drug Store Products, Inc. ANDA Current 67414-240 Motrin IB IBUPROFEN Jones Contract Packaging Services ANDA Current 67414-240 Motrin IB IBUPROFEN Jones Packaging Inc ANDA Current 67414-240 Motrin IB IBUPROFEN Jones Healthcare Group - Packaging Services, Inc ANDA Current 68391-517 berkley and jensen ibuprofen Ibuprofen BJWC ANDA Current 68391-517 berkley and jensen ibuprofen Ibuprofen BJWC ANDA Current 68391-517 berkley and jensen ibuprofen Ibuprofen BJWC ANDA Current 69168-390 Ibuprofen 200mg Ibuprofen 200mg Allegiant Health ANDA Current 69842-183 Ibuprofen Ibuprofen CVS Pharmacy ANDA Current 69842-183 Ibuprofen Ibuprofen CVS Pharmacy ANDA Current 70000-0003 leader ibuprofen Ibuprofen Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0003 leader ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0003 leader ibuprofen Ibuprofen Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0308 leader ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0308 leader ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0308 leader ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0308 leader ibuprofen Ibuprofen Cardinal Health 110, LLC. dba Leader ANDA Current 72288-517 basic care ibuprofen Ibuprofen Amazon.com Services LLC ANDA Current 72288-517 basic care ibuprofen Ibuprofen Amazon.com Services LLC ANDA Current