FDA.reportPublic FDA data

Application 206952

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATEHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE; ORAL10MGNoNo
005HYDROCODONE BITARTRATEHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hysingla ERHYDROCODONE BITARTRATEKnoa Pharma LLCb7d23ac2-e776-9f62-3290-c64c2d6eb3532026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROCODONE BITARTRATE
Hydrocodone BitartrateHYDROCODONE BITARTRATEAlvogen Inc.f7b55d14-0980-b680-8ceb-7489ff65455e2025-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate
generic name: HYDROCODONE BITARTRATE
Hydrocodone BitartrateHYDROCODONE BITARTRATEAlvogen Inc.a7b8ea07-e926-f0a5-c20d-92f23ed350d02023-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate
generic name: HYDROCODONE BITARTRATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45819APPL2016-11-04