Application 207419

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207419-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORALAA2017-03-22
A207419-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2017-03-22
A207419-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2017-03-22
A207419-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2017-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A207419-001AA
A207419-002AA
A207419-003AA
A207419-004AA

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-2284e616aacf4f…
2026-09-14 22:38:342026-08A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-2284e616aacf4f…
2026-09-14 22:38:342026-08A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-2284e616aacf4f…
2026-09-14 22:38:342026-08A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-2284e616aacf4f…
2026-08-18 06:07:402026-07A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-03-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207419-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A207419-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A207419-003AA184e616aacf4f…
2026-09-14 22:38:342026-08A207419-004AA184e616aacf4f…
2026-08-18 06:07:402026-07A207419-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A207419-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A207419-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A207419-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207419-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207419-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207419-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207419-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207419-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207419-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207419-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207419-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207419-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207419-004AA15bbf6a4d5a75…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.42777191-0454-4ccb-8fc3-8b18b0ee43f72025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_Rx90a11364-fc42-e94e-e053-2a95a90a97822025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.71c7a627-6ed9-4f49-8cdc-b3228c021e642025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENDirect_Rxe4e27022-581e-ba8c-e053-2a95a90a1ae42025-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 72189-368
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.9e4024f4-0f60-dfef-e053-2995a90ac3662024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.925f9787-3d1c-0189-e053-2a95a90a29722024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4a873428-bb5a-4e48-9185-2a27f289110d2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 71335-2106
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack88d05136-7b04-4b25-af1c-6bc72fdbcbd72024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 71335-1959
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack96173ce4-4836-43ae-9797-5246f830643a2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 71335-2041
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3791abd3-fcdf-4c8d-b46d-db6e5c8057702024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack0c85d1b8-ea42-421d-a305-4d338b47150f2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4da8a7bd-0d2e-452c-afb5-fed4e230a9bd2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 71335-1953
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.7f3c6dd7-6bc8-450e-aded-997f9cf63a8f2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 72865-116
ndc (product): 72865-113
ndc (product): 72865-115
ndc (product): 72865-114
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP78933d4a-d78a-43bc-9052-a032901ee0502022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
ndc (product): 71205-486
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP5df7c033-0f31-45bc-8c34-3da45635e66d2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP484a4323-0758-439d-844f-f04d7e5ef6f32022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.2a49ee34-6f1d-4ed3-8daa-343723d2a2be2018-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207419
application number: ANDA207419

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 104 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71205-486Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
71335-0722Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0722Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1070Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1216Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1216Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1953Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1953Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1959Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2041Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2106Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
72189-357Oxycodone and AcetaminophenOxycodone and AcetaminophenDirect_RxANDACurrent
72189-357Oxycodone and AcetaminophenOxycodone and AcetaminophenDirect_RxANDACurrent
72189-357Oxycodone and AcetaminophenOxycodone and AcetaminophenDirect_RxANDACurrent
72189-368Oxycodone and AcetaminophenOxycodone and AcetaminophenDirect_RxANDACurrent
72189-368Oxycodone and AcetaminophenOxycodone and AcetaminophenDirect_RxANDACurrent
72865-113Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-113Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-114Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-114Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-115Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-115Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-116Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent
72865-116Oxycodone and AcetaminophenOxycodone and AcetaminophenXLCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76532ORIG 2023-11-08