APPLICATION
ANDA089173
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-18
LATEST ACTION
1997-10-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
A-METHAPREDDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
1997-10-23Manufacturing (CMC) · Supplement 14AP
1995-05-10Manufacturing (CMC) · Supplement 12AP
1994-03-17Labeling · Supplement 11AP
1994-02-04Manufacturing (CMC) · Supplement 10AP
1993-10-13Labeling · Supplement 9AP
1992-10-30Manufacturing (CMC) · Supplement 8AP
1992-03-06Manufacturing (CMC) · Supplement 7AP
1992-01-10Labeling · Supplement 6AP
1991-08-19Manufacturing (CMC) · Supplement 2AP
1990-11-29Manufacturing (CMC) · Supplement 3AP
1990-11-20Manufacturing (CMC) · Supplement 4AP
1990-01-10Labeling · Supplement 5AP
1987-08-18OriginalAP
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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