FDA.reportPublic FDA data

Application 203573

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDESOLUTION;ORAL325MG/5ML;5MG/5MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride and Acetaminophen
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride and Acetaminophen
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy53de17b1-6d5b-c7c0-e063-6394a90a70642026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride and Acetaminophen
oxycodone hydrochloride and acetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENFH2 Pharma LLC96b0067e-aabe-df4f-e053-2995a90a4a862026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxycodone hydrochloride and acetaminophen
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENElite Laboratories, Inc.27fa8190-d334-4bb9-b277-d1f44db433e32026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride and Acetaminophen

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76154ORIG 2023-11-03
32445ORIG2014-12-23