FDA.reportPublic FDA data

Application 076713

Type
ANDA
Sponsor
ANDRX PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDETABLET; ORALEQ 250MG BASENoNo

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 4 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEA-S Medication Solutions6605103b-fd71-4438-8496-f48973b989012023-10-31Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEProficient Rx LP4e515f99-7fc7-4692-9105-8e87c27d4e792022-08-01Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEProficient Rx LP76f7525d-2005-4da8-a795-50ede6236c682022-07-01WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDETERBINAFINE TABLETS 250 MGCipla USA Inc.daf41866-6f2b-4483-b575-456becd6e85f2021-01-05Warnings, Adverse reactionsName fallback
brand name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC808dab18-43f1-4895-a023-edbde722863e2017-12-15Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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