APPLICATION
ANDA040323
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-13
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISOLONEPrescription
PREDNISOLONE 15MG/5ML · SOLUTION · ORAL
Approval history
2024-06-05Labeling · Supplement 10 · standardAP
2003-01-22Labeling · Supplement 5AP
2002-01-30Manufacturing (CMC) · Supplement 1AP
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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