Halobetasol Propionate
Halobetasol Propionate Cream, 0.05%
Approved
Approval ID
b123de3e-e0a3-4869-8a27-38bc7ed40890
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2017
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 Code51672-1321
Application NumberANDA077227
Product Classification
M
Marketing Category
C73584
G
Generic Name
Halobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2017
FDA Product Classification
INGREDIENTS (10)
steareth-21Inactive
Code: 53J3F32P58
Classification: IACT
methylchloroisothiazolinoneInactive
Code: DEL7T5QRPN
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
diazolidinyl ureaInactive
Code: H5RIZ3MPW4
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
isopropyl isostearateInactive
Code: C67IXB9Y7T
Classification: IACT
isopropyl palmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
Halobetasol PropionateActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
methylisothiazolinoneInactive
Code: 229D0E1QFA
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT