Prednisolone Sodium Phosphate
Prednisolone Sodium Phosphate Oral Solution
Approved
Approval ID
de240524-7865-46a2-aa11-d06356ba9339
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-102
Application NumberANDA078345
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisolone Sodium Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (9)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PREDNISOLONE SODIUM PHOSPHATEActive
Quantity: 15 mg in 5 mL
Code: IV021NXA9J
Classification: ACTIM
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT