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FDA ANDA · ANDA085854

A-METHAPRED

Sponsor: HOSPIRA

APPLICATION
ANDA085854
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 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

1997-10-23Manufacturing (CMC) · Supplement 35AP
1997-07-28Manufacturing (CMC) · Supplement 34AP
1996-02-07Manufacturing (CMC) · Supplement 32AP
1994-03-25Labeling · Supplement 31AP
1994-02-04Manufacturing (CMC) · Supplement 30AP
1993-10-15Manufacturing (CMC) · Supplement 29AP
1993-08-12Labeling · Supplement 28AP
1991-03-25Labeling · Supplement 26AP
1991-01-30Labeling · 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 18AP
1984-01-20Manufacturing (CMC) · Supplement 16AP
1984-01-20Manufacturing (CMC) · Supplement 17AP
1983-06-15Manufacturing (CMC) · Supplement 14AP
1983-06-15Manufacturing (CMC) · Supplement 12AP
1982-09-08Manufacturing (CMC) · Supplement 8AP
1982-09-08Manufacturing (CMC) · Supplement 6AP
1978-03-28OriginalAP
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