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 3 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curist Antifungal ReliefTERBINAFINE HYDROCHLORIDELittle Pharma, Inc.28f13725-48d1-8774-e063-6394a90a67042025-06-15WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack5a921005-304e-4f5b-b9ba-681749e2499b2025-02-03Warnings, Adverse reactionsName fallback
brand name: terbinafine hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.7f8434c2-60c9-4aeb-b0b8-f69107e746092025-01-09WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.0f59271d-997f-4dcc-aae3-900b53df1c952025-01-09WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEDr.Reddys Laboratories Limitede0b309a5-bebe-c6da-2847-bda21aa488b12024-12-19Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEBionpharma Inc.34221c17-0d8c-4b56-8af3-c74efab4599e2024-12-18Warnings, Adverse reactionsName fallback
brand name: terbinafine hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEA-S Medication Solutions8f6d7b1a-5a01-4cc5-b5b7-c126ae8895572024-10-14Warnings, Adverse reactionsName fallback
brand name: terbinafine hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP0a54cc4f-0789-46ce-875f-df759aa95d9c2024-09-01Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack17e976c6-ee44-42c5-987f-5360ee6d7c1e2024-08-29Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5d01fde5-e4cf-6670-e053-2991aa0a5b152024-07-15Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.87af930f-493c-590e-e053-2a95a90a804a2024-06-14Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.715cae3e-4e86-48b3-e053-2a95a90afdc22024-06-10Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack294bc1af-50e3-4bff-8d48-321e673033ce2024-05-30Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions79a39fb1-12b7-4b1e-9f28-102af34d04592024-05-23Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEAurobindo Pharma Limited6600e2b3-65df-4fc3-8081-d574537d27e32024-04-18Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDENorthStar Rx LLC8f87e3e1-4c9c-497a-af20-8ab52cfeef602024-04-18Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP50657431-1cd9-42dd-9cfc-57db8713d2672024-04-01Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepacke2ecf7a5-1c84-4977-8a87-d1bfb96586682024-02-07Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.c3832113-f517-4b4e-bf9c-31fce1a638e12023-12-22Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEA-S Medication Solutionsef8370dc-8ca4-411d-87e1-dc6af31913302023-12-09WarningsName 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.