← FDA DRUG APPROVALS

FDA ANDA · ANDA085852

A-METHAPRED

Sponsor: HOSPIRA

APPLICATION
ANDA085852
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 1GM 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 27AP
1991-03-25Labeling · Supplement 26AP
1990-11-20Manufacturing (CMC) · Supplement 25AP
1986-04-21Manufacturing (CMC) · Supplement 23AP
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
1982-07-09Manufacturing (CMC) · Supplement 8AP
1981-08-05Manufacturing (CMC) · Supplement 9AP
1978-03-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →