FDA.reportPublic FDA data

Application 090734

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090734-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORAL2013-07-11
A090734-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / 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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090734-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A090734-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-07-11782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090734-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090734-002AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090734-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090734-002AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090734-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090734-002AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090734-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090734-002AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090734-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090734-002AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090734-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A090734-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090734-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090734-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090734-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090734-002AA1ea99ee380514…

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 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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4979Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0603-4979Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4979Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4982Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0603-4982Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0603-4982Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenPar PharmaceuticalANDACurrent
0904-6438Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6438Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6439Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6439Oxycodone and AcetaminophenOxycodone hydrochloride and AcetaminophenMajor PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76177ORIG 2023-11-03