FDA.reportPublic FDA data

Application 090733

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo

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
A090733-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORAL2013-07-11

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 UTC2026-02A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-113f01610625f2…
2019-09-15 20:21 UTC2019-09A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090733-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-07-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090733-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090733-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090733-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090733-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090733-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090733-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090733-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090733-001AA1ea99ee380514…

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxycodone and acetaminophenOXYCODONE AND ACETAMINOPHENFH2 Pharma LLC88d97caf-bcf5-3cde-e053-2995a90acf4a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENMajor Pharmaceuticals1d52272f-a607-4002-a61c-341964522b822026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackac6b4a26-7ead-458e-8a3d-591aa07093432026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack25c03c47-0057-41b6-a530-c6ea85eb750f2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackef2c1fe2-75dd-43cf-871d-540c5e36d3632026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackfcb09a57-76d8-413c-801b-8d8ea0c3f1db2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack1c793d37-cbc9-4d76-a84a-d076b51011432026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd1cb17-4aea-a750-e063-6394a90a95942026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd2e535-dd11-4bfb-e063-6394a90a9fbc2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENEywa Pharma Inc1da85ac1-46a2-4081-b533-4890ec9e04822026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cf4c474-556e-5ebf-e063-6394a90acaf02026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4d9e7c39-3e71-48c7-87c7-302db1835f112026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepacke6c47385-638a-41cd-93d9-b7ee205aa0942026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRhodes Pharmaceuticals LLC5999f3c3-3225-4d24-82cd-0b8d7a3095872026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.f9cf218c-af5e-4249-aa3b-a8555ed022782026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack639aba0b-1ef6-415f-9732-ebf52bcc1b862026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3339d3bd-b416-4c5b-8984-0c376544d8a92026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAvPAK7055acd5-1cbb-397e-e053-2a91aa0a38522026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4978Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4978Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4978Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76173ORIG 2023-11-03