APPLICATION
NDA017466
TYPE
NDA
ORIGINAL APPROVAL
1974-03-25
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRICANYLDiscontinued
TERBUTALINE SULFATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2007-12-07Efficacy · Supplement 5AP
2007-12-07Labeling · Supplement 6AP
2007-12-07Labeling · Supplement 23 · standardAP
2007-12-07Labeling · Supplement 2AP
1998-03-23Manufacturing (CMC) · Supplement 22 · priorityAP
1997-10-08Efficacy · Supplement 24 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 20 · priorityAP
1988-02-03Labeling · Supplement 21AP
1986-07-24Labeling · Supplement 19AP
1985-06-25Labeling · Supplement 18AP
1983-11-02Labeling · Supplement 17AP
1983-03-01Labeling · Supplement 16AP
1982-07-08Manufacturing (CMC) · Supplement 15 · priorityAP
1982-02-02Manufacturing (CMC) · Supplement 14 · priorityAP
1981-03-03Labeling · Supplement 11AP
1981-01-19Labeling · Supplement 13AP
1980-11-24Labeling · Supplement 12AP
1979-11-09Labeling · Supplement 10AP
1979-08-07Labeling · Supplement 9AP
1978-10-12Labeling · Supplement 8AP
1976-12-21Manufacturing (CMC) · Supplement 7 · priorityAP
1975-10-03Labeling · Supplement 4AP
1975-07-21Manufacturing (CMC) · Supplement 3 · priorityAP
1974-03-25Type 1 - New Molecular Entity · Original · priorityAP
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.
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