Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products2
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
50090-2341Application Number
NDA019579Marketing Category
NDA authorized generic (C73605)Route of Administration
VAGINALEffective Date
August 20, 2014ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
TerconazoleActive
Code: 0KJ2VE664UClass: ACTIBQuantity: 4 mg in 1 g
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
TERCONAZOLE
Product Details
NDC Product Code
50090-1901Application Number
NDA019964Marketing Category
NDA authorized generic (C73605)Route of Administration
VAGINALEffective Date
August 20, 2014BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
TerconazoleActive
Code: 0KJ2VE664UClass: ACTIBQuantity: 8 mg in 1 g
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT