Alclometasone Dipropionate
Alclometasone Dipropionate Cream USP, 0.05% Alclometasone Dipropionate Ointment USP, 0.05%
Approved
Approval ID
63e635e0-65d8-4b30-9f2a-ab16deba90bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2021
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 2
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 Code68462-300
Application NumberANDA079061
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alclometasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (11)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCLOMETASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: S56PQL4N1V
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
Alclometasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-299
Application NumberANDA079227
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alclometasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (5)
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
ALCLOMETASONE DIPROPIONATEActive
Quantity: .5 mg in 1 g
Code: S56PQL4N1V
Classification: ACTIB
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
PROPYLENE GLYCOL MONOPALMITOSTEARATEInactive
Code: F76354LMGR
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT