psorcon
psorcon (diflorasone diacetate cream, USP) 0.05%
Approved
Approval ID
de40cc65-f955-423f-9cbd-bc2245c4f982
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2018
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 Code51672-5292
Application NumberANDA075508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diflorasone Diacetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 5, 2018
FDA Product Classification
INGREDIENTS (15)
Diflorasone DiacetateActive
Quantity: 5 mg in 1 g
Code: 7W2J09SCWX
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
lanolin alcoholsInactive
Code: 884C3FA9HE
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 stearateInactive
Code: YD01N1999R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
polyoxyl 40 stearateInactive
Code: 13A4J4NH9I
Classification: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT