Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
Aurobindo Pharma Limited
918917642
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine
Product Details
NDC Product Code
65862-079Application Number
ANDA078297Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 22, 2022MICROCRYSTALLINE 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
TerbinafineActive
Code: 012C11ZU6GClass: ACTIMQuantity: 250 mg in 1 1