Terconazole
Terconazole Vaginal Suppositories 80 mg
Approved
Approval ID
38cd1718-6b3c-415d-a17f-7b399adb0ba2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2022
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0552
Application NumberANDA077553
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terconazole
Product Specifications
Route of AdministrationVAGINAL
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (4)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
PALM KERNEL OILInactive
Code: B0S90M0233
Classification: IACT
TERCONAZOLEActive
Quantity: 80 mg in 1 1
Code: 0KJ2VE664U
Classification: ACTIB