APPLICATION
ANDA075988
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-25
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISOLONE SODIUM PHOSPHATEPrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML · SOLUTION · ORAL
Approval history
2024-06-05Labeling · Supplement 10 · standardAP
2020-03-05Manufacturing (CMC) · Supplement 6 · unknownAP
2005-06-09Labeling · Supplement 3AP
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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