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FDA Approval

Clotrimazole and Betamethasone Dipropionate

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
December 15, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole(10 mg in 1 mL)
Betamethasone(0.5 mg in 1 mL)

Products1

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

Clotrimazole and Betamethasone Dipropionate

Product Details

NDC Product Code
0168-0370
Application Number
ANDA076516
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
December 15, 2015
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Code: G07GZ97H65Class: ACTIBQuantity: 10 mg in 1 mL
Code: 826Y60901UClass: ACTIMQuantity: 0.5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
CETEARETH-30Inactive
Code: 1R9DCZ5FOXClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
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