Home Applications 040341 Application 040341
Type ANDA
Sponsor VINTAGE PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 500MG;7.5MG No No 002 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 650MG;10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040341-001 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500MG;7.5MG TABLET / ORAL 1999-07-26 A040341-002 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 650MG;10MG TABLET / ORAL 1999-07-26
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 2 of 3 · 86 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 2022-03-09 01:35 UTC 2022-03 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040341-001 PERCOCET 500MG;7.5MG TABLET / ORAL 1999-07-26 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A040341-002 PERCOCET 650MG;10MG TABLET / ORAL 1999-07-26 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Percocet OXYCODONE/APAP Direct_Rx ee151649-b52a-0a51-e053-2a95a90a6c35 2025-01-22 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Percocet
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 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63629-3773 PERCOCET oxycodone hydrochloride and acetaminophen Bryant Ranch Prepack ANDA Current 63629-3776 PERCOCET oxycodone hydrochloride and acetaminophen Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 17773 SUPPL 2006-11-30 22130 ORIG 1999-07-26 7630 ORIG 1999-07-26