DUREZOL
DUREZOL® (difuprednate ophthalmic emulsion) 0.05%Initial U.S. Approval: 2008
Approved
Approval ID
40ac0711-e2c3-4753-ac58-cb99f558f293
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2011
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.
DUREZOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6296
Application NumberNDA022212
Product Classification
M
Marketing Category
C73594
G
Generic Name
DUREZOL
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 2, 2011
FDA Product Classification
INGREDIENTS (8)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIFLUPREDNATEActive
Quantity: 0.5 mg in 1 mL
Code: S8A06QG2QE
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT