Alclometasone Dipropionate
ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
Approved
Approval ID
6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 4, 2019
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 Code0168-0263
Application NumberANDA076973
Product Classification
M
Marketing Category
C73584
G
Generic Name
alclometasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 5, 2018
FDA Product Classification
INGREDIENTS (11)
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 4500Inactive
Code: TVH7653921
Classification: IACT
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
ALCLOMETASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: S56PQL4N1V
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT