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 1 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.2886b2ff-815f-4621-bc28-1fea082c19202026-07-09Warnings, Adverse reactionsName fallback
brand name: terbinafine hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDETERBINAFINE TABLETS 250 MGGolden State Medical Supply, Inc.50750500-6cb0-62dc-e063-6294a90a15bc2026-04-27Warnings, Adverse reactionsName fallback
brand name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEScholl's Wellness Company LLC31f59302-eaee-211b-e063-6294a90a08b02026-04-03WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEAmerican Health Packaging4ee1b667-0cf6-46e4-a740-4fc27904d5772026-03-06Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDETERBINAFINE TABLETS 250 MGNuCare Pharmaceuticals,Inc.bf020c17-578f-74c4-e053-2995a90a9e7d2026-03-02Warnings, Adverse reactionsName fallback
brand name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92b31fc4-0f02-4857-b11f-49b9f942ee842026-02-20WarningsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDETERBINAFINE TABLETS 250 MGAmici Pharma, Inc.dd8724e9-bef9-4258-b536-9c6d872c3bf82026-02-18Warnings, Adverse reactionsName fallback
brand name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.44c6f6e7-e0c0-450e-83ce-1ed4f3efddec2026-02-13Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENorthwind Health Company, LLCab6f50a5-87ce-0819-e053-2a95a90a22b72026-01-01Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions5de4c245-7086-453b-b90a-7a1242ec2c0b2025-12-18Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.21f1bf77-4338-4b75-b513-80a0d98a722a2025-12-12WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.d3e75665-e2d4-47d9-baaa-93817b5fbf002025-12-12WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Walgreens Athletes FootTERBINAFINE HYDROCHLORIDEWalgreen Companyd706c56f-0123-4a5a-8c85-240cbe6ef7a52025-11-26WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEGolden State Medical Supply, Inc.b43e4644-024c-4aa6-b403-19152c7858022025-11-25Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEVoyant Beauty Inc.9dea4789-bf1c-1577-e053-2a95a90a53812025-11-18WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0a9e890c-1eed-4fde-a484-852a4dd135c22025-10-17WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2df111dc-ecac-4161-9e22-38436eb37c1f2025-10-17Warnings, Adverse reactionsName fallback
brand name: Terbinafine Hydrochloride
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.747fdc13-7c3a-4672-b50c-31c51037bda22025-10-14Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE