APPLICATION
ANDA071786
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-05
LATEST ACTION
2004-05-20
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
METAPROTERENOL SULFATEDiscontinued
METAPROTERENOL SULFATE 0.4% · SOLUTION · INHALATION
Approval history
2004-05-20Labeling · Supplement 19AP
2004-04-01Labeling · Supplement 17AP
2002-12-20Manufacturing (CMC) · Supplement 15AP
2002-12-20Manufacturing (CMC) · Supplement 13AP
1997-03-03Manufacturing (CMC) · Supplement 10AP
1994-05-17Labeling · Supplement 9AP
1994-04-21Manufacturing (CMC) · Supplement 8AP
1993-07-16Manufacturing (CMC) · Supplement 7AP
1992-05-01Labeling · Supplement 6AP
1992-03-30Manufacturing (CMC) · Supplement 4AP
1992-03-30Manufacturing (CMC) · Supplement 5AP
1989-04-13Manufacturing (CMC) · Supplement 2AP
1989-04-13Manufacturing (CMC) · Supplement 1AP
1988-08-05OriginalAP
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.