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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
Stat Rx USA
DUNS: 786036330
Effective Date
October 27, 2009
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
16590-291
Application Number
ANDA040401
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 27, 2009
Code: 9PHQ9Y1OLMClass: ACTIBQuantity: 15 mg in 5 mL
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