Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
direct rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
direct rx
direct rx
direct rx
079254320
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
72189-243Application Number
ANDA078297Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 23, 2021CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TerbinafineActive
Code: 012C11ZU6GClass: ACTIMQuantity: 250 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT