Diflorasone Diacetate
Diflorasone Diacetate Ointment USP, 0.05%
Approved
Approval ID
20b7f7d9-bf45-4533-8173-6f1650388c66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2018
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.
Diflorasone Diacetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-063
Application NumberANDA210753
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diflorasone Diacetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 20, 2018
FDA Product Classification
INGREDIENTS (4)
Diflorasone DiacetateActive
Quantity: 0.5 mg in 1 g
Code: 7W2J09SCWX
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT