Home Applications 085106 Application 085106
Type ANDA
Sponsor VINTAGE PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A085106-002 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982
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 2 · 44 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 2022-10-28 04:53 UTC 2022-10 A085106-002 PERCOCET 325MG;5MG TABLET / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A085106-002 PERCOCET 325MG;5MG TABLET / ORAL RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A085106-002 PERCOCET 325MG;5MG TABLET / ORAL RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A085106-002 PERCOCET 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 a50c72e98297…
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.
Documents# Document, Submission type, Date table Document Submission type Date 76185 ORIG 2023-11-03