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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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 Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-06-25Boxed 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

Documents#

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