Halobetasol Propionate
Halobetasol Propionate Ointment, 0.05%
Approved
Approval ID
1b3fd144-9ebd-46b0-b240-8bca47d101cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2020
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-1322
Application NumberANDA076994
Product Classification
M
Marketing Category
C73584
G
Generic Name
Halobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 29, 2020
FDA Product Classification
INGREDIENTS (7)
aluminum stearateInactive
Code: U6XF9NP8HM
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Halobetasol PropionateActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
sorbitan sesquioleateInactive
Code: 0W8RRI5W5A
Classification: IACT
monostearyl citrateInactive
Code: YWW937R1QR
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT