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FDA Approval

Clotrimazole

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

FDA Approval Summary

Company
Effective Date
April 29, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Clotrimazole(10 mg in 1 g)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clotrimazole

Product Details

NDC Product Code
70000-0729
Application Number
ANDA074165
Marketing Category
ANDA (C73584)
Route of Administration
VAGINAL
Effective Date
April 29, 2025
Code: G07GZ97H65Class: ACTIBQuantity: 10 mg in 1 g
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GUClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58XClass: IACT
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