Prednisolone Sodium Phosphate
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 mg/5 mL Rx only
Approved
Approval ID
9f4b181e-2675-40c6-a3d7-a8fe671230c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2021
Manufacturers
FDA
Morton Grove Pharmaceuticals, Inc.
DUNS: 801897505
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 Code60432-212
Application NumberANDA076895
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisolone Sodium Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2021
FDA Product Classification
INGREDIENTS (9)
PREDNISOLONE SODIUM PHOSPHATEActive
Quantity: 15 mg in 5 mL
Code: IV021NXA9J
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT