APPLICATION
ANDA083283
TYPE
ANDA
ORIGINAL APPROVAL
1974-11-15
LATEST ACTION
2000-03-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOPROTERENOL HYDROCHLORIDEDiscontinued
ISOPROTERENOL HYDROCHLORIDE 0.02MG/ML · INJECTABLE · INJECTION
Approval history
2000-03-08Labeling · Supplement 33AP
1997-01-29Labeling · Supplement 34AP
1995-02-23Manufacturing (CMC) · Supplement 32AP
1992-06-01Labeling · Supplement 31AP
1991-02-05Manufacturing (CMC) · Supplement 27AP
1989-07-26Manufacturing (CMC) · Supplement 25AP
1989-03-24Labeling · Supplement 26AP
1988-06-03Labeling · Supplement 24AP
1988-04-04Manufacturing (CMC) · Supplement 21AP
1988-04-04Manufacturing (CMC) · Supplement 22AP
1986-06-13Manufacturing (CMC) · Supplement 18AP
1986-06-13Manufacturing (CMC) · Supplement 19AP
1986-06-13Manufacturing (CMC) · Supplement 17AP
1984-01-03Manufacturing (CMC) · Supplement 16AP
1982-10-05Manufacturing (CMC) · Supplement 12AP
1974-11-15OriginalAP
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.