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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203573-001OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN325MG/5ML;5MG/5MLSOLUTION / ORAL2014-12-183a93d1ddd44b…
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…

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