Terbinafine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 829572556

Effective Date

December 13, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Terbinafine(250 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70518-3919

Application Number

ANDA078297

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2023

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: 012C11ZU6GClass: ACTIMQuantity: 250 mg in 1 1