Alclometasone Dipropionate
ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
Approved
Approval ID
0c2fb9a0-5586-4428-b705-5fa179a73e08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 3, 2020
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alclometasone dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0264
Application NumberANDA076884
Product Classification
M
Marketing Category
C73584
G
Generic Name
alclometasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 21, 2018
FDA Product Classification
INGREDIENTS (5)
ALCLOMETASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: S56PQL4N1V
Classification: ACTIB
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLENE GLYCOL MONOSTEARATEInactive
Code: MZM1I680W0
Classification: IACT