APPLICATION
ANDA040192
TYPE
ANDA
ORIGINAL APPROVAL
1998-05-28
LATEST ACTION
2002-09-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
PREDNISOLONEDiscontinued
PREDNISOLONE 15MG/5ML · SOLUTION · ORAL
Approval history
2002-09-16Labeling · Supplement 8AP
2002-04-12Manufacturing (CMC) · Supplement 7AP
2000-08-28Manufacturing (CMC) · Supplement 2AP
2000-08-28Manufacturing (CMC) · Supplement 3AP
1998-07-16Labeling · 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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