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 2 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.1aa5e03a-432b-4154-ab6e-6dbce7a671092025-10-02WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc6016e546-6c02-4af0-888c-c0899865c5f02025-09-30WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.085e0809-6b7f-447e-976e-8276c29daad62025-09-30Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
CVS Pharmacy Athletes FootTERBINAFINE HYDROCHLORIDECVS Pharmacy98a4ed66-2813-49de-8cda-94c41cc3ca9f2025-09-25WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Athletes FootTERBINAFINE HYDROCHLORIDEPublix Super Markets Inc.58293d62-089d-49ab-b691-dfd705ac9a9c2025-09-25WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack838c6140-19b6-4c2b-aed7-3065bd67af072025-09-18Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
LAMISIL AT TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEVoyant Beauty, Inc.1fd313ad-a3d9-6c86-e063-6394a90a7ae42025-09-17WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEProficient Rx LP53235270-6ffb-44c8-aa55-debf59e1d9642025-09-01Warnings, Adverse reactionsName fallback
brand name: terbinafine hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
equate Athletes FootTERBINAFINE HYDROCHLORIDEWal-Mart Stores Ince799c808-7c0f-482d-99d2-35fc34dbb2ea2025-08-14WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEAmerisourceBergen93ea9e7f-6914-4df2-8ca0-27c4538066232025-07-28WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Athletes FootTERBINAFINE HYDROCHLORIDERite Aid Corporationa7b0a70b-a117-48cf-a6bc-260be1dac1e72025-07-28WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC28a3ece3-78fb-4121-86a7-adc4a9d9540f2025-07-21WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Athletes FootTERBINAFINE HYDROCHLORIDEH E B28db9a27-4d23-48ef-b1f3-08b993948c112025-07-15WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Kroger AntifungalTERBINAFINE HYDROCHLORIDEKroger Company32e79416-5de4-4f06-9fff-f8c36a1ad5db2025-07-15WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEWALGREEN COMPANY2ba1924b-9967-4adb-9061-d023ef44ab3e2025-07-10WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDECardinal Health, 110 dba LEADERa9412747-c7f9-4242-91ed-3695f372f6c92025-07-09WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Silka AntifungalTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.a32cf699-e63e-4bd3-a5af-9e1ba447e02e2025-07-02WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Silka Jock ItchTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.326d8586-042f-44f8-8530-e46b7b777bc32025-07-02WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
AntifungalTERBINAFINE HYDROCHLORIDEMeijer Distribution Inc9daf3136-74b6-4410-8256-cbc9dd700f612025-07-02WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ca9cd2bd-4805-4469-b754-01a7487b71a62025-07-01WarningsName 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.