Application 207510

Type
ANDA
Sponsor
WES PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
003OXYCODONE 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207510-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2018-03-21
A207510-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2018-03-21
A207510-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2018-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207510-001AA
A207510-002AA
A207510-003AA

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 UTC2026-02A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207510-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-218072bd15b7f6…

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 UTC2026-02A207510-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207510-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207510-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207510-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207510-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207510-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207510-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207510-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207510-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207510-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207510-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207510-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207510-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207510-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207510-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207510-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207510-001AA18072bd15b7f6…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENMajor Pharmaceuticals1d52272f-a607-4002-a61c-341964522b822026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
ndc (product): 0904-7094
ndc (product): 0904-7093
ndc (product): 0904-7095
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack25c03c47-0057-41b6-a530-c6ea85eb750f2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENEywa Pharma Inc1da85ac1-46a2-4081-b533-4890ec9e04822026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
ndc (product): 71930-047
ndc (product): 71930-045
ndc (product): 71930-046
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3339d3bd-b416-4c5b-8984-0c376544d8a92026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.e0d06ec7-9846-4e04-8660-5fd6b2b8e4232025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmerican Health Packaging79bb61d7-8836-4ce7-91bc-9463efbad9cf2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
ndc (product): 60687-642
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
ndc (product): 72189-255
ndc (product): 72189-256
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack71b1a9be-3231-4b09-a195-d5893104bd4a2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207510
application number: ANDA207510
ndc (product): 71335-2049

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenMajor PharmaceuticalsANDACurrent
43598-546oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-546oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-546oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-547oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-547oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
43598-547oxycodone and acetaminophenoxycodone and acetaminophenDr. ReddyANDACurrent
60687-642OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenAmerican Health PackagingANDACurrent
60687-642Oxycodone and AcetaminophenOxycodone and AcetaminophenAmerican Health PackagingANDACurrent
63629-1942OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
63629-1942OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
63629-1943OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
63629-1943OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
68071-2598OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2856OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
71335-2049OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenBryant Ranch PrepackANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-045OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-046OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
71930-047OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophenEywa Pharma IncANDACurrent
72189-255OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-255OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-256OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-256OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDIRECT RXANDACurrent
72189-257OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirectRxANDACurrent
72189-257OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76201ORIG 2023-11-03