APPLICATION
ANDA085855
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-28
LATEST ACTION
2002-10-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
A-METHAPREDDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2002-10-11Labeling · Supplement 35AP
1997-10-23Manufacturing (CMC) · Supplement 34AP
1997-07-28Manufacturing (CMC) · Supplement 33AP
1996-02-07Manufacturing (CMC) · Supplement 31AP
1994-03-25Labeling · Supplement 30AP
1993-10-15Manufacturing (CMC) · Supplement 29AP
1993-08-12Labeling · Supplement 28AP
1991-03-25Labeling · Supplement 26AP
1991-03-25Labeling · Supplement 27AP
1990-11-20Manufacturing (CMC) · Supplement 24AP
1986-04-23Manufacturing (CMC) · Supplement 22AP
1984-12-24Manufacturing (CMC) · Supplement 21AP
1984-04-19Manufacturing (CMC) · Supplement 14AP
1984-01-20Manufacturing (CMC) · Supplement 13AP
1984-01-20Manufacturing (CMC) · Supplement 12AP
1979-02-23Manufacturing (CMC) · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.