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FDA Approval

Terconazole

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Effective Date
March 9, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terconazole(4 mg in 1 g)

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
0168-0346
Application Number
ANDA076712
Marketing Category
ANDA (C73584)
Route of Administration
VAGINAL
Effective Date
March 9, 2021
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
Code: 0KJ2VE664UClass: ACTIBQuantity: 4 mg in 1 g
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
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