APPLICATION
ANDA216715
TYPE
ANDA
ORIGINAL APPROVAL
2022-10-25
LATEST ACTION
2025-07-23
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISOLONE SODIUM PHOSPHATEPrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-07-23Labeling · Supplement 3 · standardAP
2022-10-25UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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