Application 202677

Type
ANDA
Sponsor
ALVOGEN

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202677-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2012-07-26
A202677-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2012-07-26
A202677-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2016-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202677-001AA
A202677-002AA
A202677-003AA

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202677-002OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202677-003OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2016-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202677-001OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-07-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202677-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202677-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202677-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202677-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202677-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202677-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202677-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202677-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202677-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202677-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202677-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202677-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202677-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202677-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202677-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202677-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202677-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202677-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202677-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202677-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202677-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202677-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202677-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202677-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202677-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202677-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202677-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202677-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202677-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202677-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202677-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202677-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202677-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202677-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202677-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202677-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202677-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202677-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202677-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202677-001AA18072bd15b7f6…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd1cb17-4aea-a750-e063-6394a90a95942026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cf4c474-556e-5ebf-e063-6394a90acaf02026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAlvogen, Inc.900ec197-720e-5428-b526-055b7756aa4a2025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
ndc (product): 47781-229
ndc (product): 47781-230
ndc (product): 47781-196
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackb4cf62af-b5d3-4825-9743-9ec3137164e82025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
ndc (product): 71335-0316
ndc (product): 71335-0216
ndc (product): 71335-0146
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.223fe2b4-aa12-81fd-e063-6394a90a6c082024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmerican Health Packaging03c9ff0d-46e8-448c-944a-7ad59d1afd6d2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
ndc (product): 68084-699
ndc (product): 68084-710
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP0233de1c-466b-4842-8604-6d879aa36a4b2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202677
application number: ANDA202677
ndc (product): 63187-719
ndc (product): 63187-363

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
35356-801Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Product s LLCANDACurrent
35356-801Oxycodone and AcetaminophenOxycodone and AcetaminophenQuality Care Products, LLCANDACurrent
35356-802Oxycodone and AcetaminophenOxycodone and AcetaminophenLake Erie Medical DBA Quality Care Product s LLCANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-196Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-229Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
47781-230Oxycodone and AcetaminophenOxycodone and AcetaminophenAlvogen, Inc.ANDACurrent
61919-432OXYCODONE/APAPOXYCODONE/APAPDIRECT RXANDACurrent
61919-612OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect rxANDACurrent
61919-612OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect rxANDACurrent
63187-363Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-363Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-719Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-719Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63629-7748Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7748Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7824Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7824Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63739-636Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson CorporationANDACurrent
63739-739Oxycodone and AcetaminophenOxycodone and AcetaminophenMcKesson CorporationANDACurrent
67296-1773Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1773Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-699Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
68084-710Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
71335-0146Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0146Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0216Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0216Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0316Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0316Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76331ORIG 2023-11-03