Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Camber Pharmaceuticals,Inc.
826774775
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
InvaGen Pharmaceuticals, Inc.
Camber Pharmaceuticals, Inc.
Camber Pharmaceuticals,Inc.
165104469
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine Hydrochloride
Product Details
NDC Product Code
31722-209Application Number
ANDA077533Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 15, 2015SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TerbinafineActive
Code: 012C11ZU6GClass: ACTIMQuantity: 250 1 in 1 1