FDA.reportPublic FDA data

Application 078778

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDETABLET;ORAL325MG;37.5MGNoNo

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

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
A078778-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDE325MG;37.5MGTABLET / ORAL2014-04-07

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A078778-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2014-04-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078778-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2014-04-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078778-001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN325MG;37.5MGTABLET / ORAL2014-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078778-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A078778-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078778-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078778-001AB1ea99ee380514…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacycb05d615-918d-8104-e053-2995a90aa96b2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackccf465b5-8ef8-4445-a0d4-23b5cf13188c2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackc83366d9-db60-45eb-9c2b-a2c58d45c82c2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAvPAK244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f02026-01-12Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCd51600e2-2f73-483c-9b2e-f142bafff16d2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAurobindo Pharma Limited6c2894df-eeeb-4b22-ab32-8ce1601bfdfa2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect_Rxe8a7c995-e473-ca87-e053-2995a90a5b802025-01-22Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackf33fcd05-2c95-48dd-884b-5ed9c25c2ccf2024-08-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMedsource Pharmaceuticals12f113b3-d6b1-a7b0-e063-6294a90a999d2024-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LPd9fa3057-c7a5-46cf-a79e-abf99a4f804d2022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.52693021-f60f-43bc-9b05-43db186213462022-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LP1ad89537-3e59-438c-b646-b3c93b7908532021-01-01Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride and Acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.82d8b70f-aebf-4b9a-89b1-183fc9e2ff592020-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

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 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60429-500Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenGolden State Medical Supply, Inc.ANDACurrent
60429-500Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenGolden State Medical Supply, Inc.ANDACurrent
60429-500Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenGolden State Medical SupplyANDACurrent
60429-500Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenGolden State Medical SupplyANDACurrent
60505-2644Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenApotex Corp.ANDACurrent
60505-2644Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenApotex Corp.ANDACurrent
60505-2644Tramadol hydrochloride and acetaminophenTramadol hydrochloride and acetaminophenApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76065ORIG 2023-11-02