PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium PhosphateOphthalmic Solution USP, 1% (Sterile)
Approved
Approval ID
dbcab023-8a71-4c66-ac6b-b98b20a493f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2010
Manufacturers
FDA
MWI/VetOne
DUNS: 019926120
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PREDNISOLONE SODIUM PHOSPHATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13985-025
Application NumberANDA040070
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREDNISOLONE SODIUM PHOSPHATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 3, 2010
FDA Product Classification
INGREDIENTS (10)
PREDNISOLONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: IV021NXA9J
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT