Clobetasol Propionate
These highlights do not include all the information needed to use CLOBETASOL PROPIONATE lotion safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE lotion. CLOBETASOL PROPIONATE lotion, for topical use. Initial U.S. Approval: 1985
Approved
Approval ID
a12c2b51-710d-68cd-2531-1c28f9864d8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2016
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clobetasol Propionate
PRODUCT DETAILS
NDC Product Code52565-055
Application NumberANDA208667
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateSeptember 10, 2019
Generic NameClobetasol Propionate
INGREDIENTS (8)
Clobetasol PropionateActive
Quantity: .05 mg in 100 mL
Code: 779619577M
Classification: ACTIB
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked)Inactive
Code: 809Y72KV36
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polyethylene Glycol 300Inactive
Code: 5655G9Y8AQ
Classification: IACT