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FDA Approval

Prednisolone Sodium Phosphate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 27, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prednisolone(15 mg in 5 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Prednisolone Sodium Phosphate

Product Details

NDC Product Code
50090-1582
Application Number
ANDA076913
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 14, 2023
Code: IV021NXA9JClass: ACTIMQuantity: 15 mg in 5 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6SClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51Class: IACT
DIBASIC POTASSIUM PHOSPHATEInactive
Code: CI71S98N1ZClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
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