Diflorasone Diacetate
Diflorasone Diacetate Ointment USP, 0.05%
Approved
Approval ID
b304dfca-e840-4c03-8217-73aaa5360277
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2020
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.
Diflorasone Diacetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-1295
Application NumberANDA075331
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diflorasone Diacetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 27, 2020
FDA Product Classification
INGREDIENTS (4)
Diflorasone DiacetateActive
Quantity: 0.5 mg in 1 g
Code: 7W2J09SCWX
Classification: ACTIB
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT