Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terconazole Vaginal Cream 0.8%
Product Details
NDC Product Code
63629-8837Application Number
NDA021735Marketing Category
NDA (C73594)Route of Administration
VAGINALEffective Date
September 15, 2021TerconazoleActive
Code: 0KJ2VE664UClass: ACTIBQuantity: 8 mg in 1 g
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT