Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Taro Pharmaceuticals U.S.A., Inc.
145186370
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Cosette Pharmaceuticals NC Laboratories, LLC
Cosette Pharmaceuticals, Inc.
Taro Pharmaceuticals U.S.A., Inc.
079419931
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
0713-0552Application Number
ANDA077553Marketing Category
ANDA (C73584)Route of Administration
VAGINALEffective Date
November 23, 2022BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
COCONUT OILInactive
Code: Q9L0O73W7LClass: IACT
PALM KERNEL OILInactive
Code: B0S90M0233Class: IACT
TerconazoleActive
Code: 0KJ2VE664UClass: ACTIBQuantity: 80 mg in 1 1