Halobetasol Propionate
Approved
Approval ID
c40b91aa-cf2b-4774-a737-f2c4d5b6673f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4907
Application NumberANDA077123
Product Classification
M
Marketing Category
C73584
G
Generic Name
halobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 27, 2010
FDA Product Classification
INGREDIENTS (9)
HALOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
STEARETH-21Inactive
Code: 53J3F32P58
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT