Terbinafine Hydrochloride
Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use.Initial U.S. Approval: 1992
Approved
Approval ID
bcf7e761-786b-4ac8-aecd-ea1c745880b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2015
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-209
Application NumberANDA077533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2015
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TERBINAFINE HYDROCHLORIDEActive
Quantity: 250 1 in 1 1
Code: 012C11ZU6G
Classification: ACTIM