TERCONAZOLE
TERCONAZOLE VAGINAL CREAM 0.4%7-Day RegimenTERCONAZOLE VAGINAL CREAM 0.4%3-Day Regimen
Approved
Approval ID
426c71b4-39cf-4d12-ad6a-8f64a7c15490
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-811
Application NumberNDA019579
Product Classification
M
Marketing Category
C73594
G
Generic Name
terconazole
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 19, 2012
FDA Product Classification
INGREDIENTS (9)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
TERCONAZOLEActive
Quantity: 4 mg in 1 g
Code: 0KJ2VE664U
Classification: ACTIM
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT