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FDA Approval

Prednisolone

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

FDA Approval Summary

Company
Effective Date
January 23, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prednisolone(15 mg in 5 mL)

Products1

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

Prednisolone

Product Details

NDC Product Code
33261-475
Application Number
ANDA089081
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 23, 2014
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Code: 9PHQ9Y1OLMClass: ACTIBQuantity: 15 mg in 5 mL
BENZOIC ACIDInactive
Code: 8SKN0B0MIMClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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