Halobetasol Propionate
HALOBETASOL PROPIONATE OINTMENT, 0.05%
Approved
Approval ID
b840b012-ef8e-4637-8e48-b1c867e7a050
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Halobetasol Propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-961
Application NumberANDA076872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Halobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 2, 2011
FDA Product Classification
INGREDIENTS (6)
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
Halobetasol PropionateActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
ALUMINUM STEARATEInactive
Code: U6XF9NP8HM
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT