Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
H.J. Harkins Company, Inc.
147681894
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
H.J. Harkins Company, Inc.
H.J. Harkins Company, Inc.
H.J. Harkins Company, Inc.
147681894
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TERCONAZOLE
Product Details
NDC Product Code
52959-811Application Number
NDA019579Marketing Category
NDA (C73594)Route of Administration
VAGINALEffective Date
January 19, 2012BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
TerconazoleActive
Code: 0KJ2VE664UClass: ACTIMQuantity: 4 mg in 1 g
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT