APPLICATION
NDA006328
TYPE
NDA
ORIGINAL APPROVAL
1948-02-19
LATEST ACTION
1998-05-12
ROUTE
RECTAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISUPRELDiscontinued
ISOPROTERENOL HYDROCHLORIDE 10MG · TABLET · RECTAL, SUBLINGUAL
ISUPRELDiscontinued
ISOPROTERENOL HYDROCHLORIDE 15MG · TABLET · RECTAL, SUBLINGUAL
Approval history
1998-05-12Labeling · Supplement 7AP
1998-05-12Labeling · Supplement 5AP
1998-05-12Labeling · Supplement 3AP
1987-05-27Labeling · Supplement 13AP
1985-05-13Labeling · Supplement 12AP
1981-02-04Labeling · Supplement 9AP
1980-09-17Labeling · Supplement 6AP
1980-09-12Labeling · Supplement 8AP
1975-06-02Labeling · Supplement 2AP
1948-02-19UNKNOWN · Original · unknownAP
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.