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Halobetasol Propionate

Approved
Approval ID

f5304f1d-8e0d-4040-becf-ed1abf5faaa4

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 Code54868-5482
Application NumberANDA076872
Product Classification
M
Marketing Category
C73584
G
Generic Name
halobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 27, 2010
FDA Product Classification

INGREDIENTS (6)

HALOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 91A0K1TY3Z
Classification: ACTIB
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HM
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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Halobetasol Propionate - FDA Drug Approval Details