APPLICATION
ANDA085853
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-28
LATEST ACTION
1997-10-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
A-METHAPREDDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
1997-10-23Manufacturing (CMC) · Supplement 29AP
1996-02-07Manufacturing (CMC) · Supplement 27AP
1994-03-25Labeling · Supplement 26AP
1993-10-15Manufacturing (CMC) · Supplement 25AP
1993-08-12Labeling · Supplement 24AP
1990-04-13Labeling · Supplement 23AP
1990-04-13Labeling · Supplement 22AP
1986-04-23Manufacturing (CMC) · Supplement 19AP
1984-12-24Manufacturing (CMC) · Supplement 18AP
1984-04-19Manufacturing (CMC) · Supplement 15AP
1984-01-20Manufacturing (CMC) · Supplement 13AP
1984-01-20Manufacturing (CMC) · Supplement 14AP
1982-09-02Manufacturing (CMC) · Supplement 8AP
1978-03-28OriginalAP
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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