APPLICATION
NDA017618
TYPE
NDA
ORIGINAL APPROVAL
1975-04-22
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BRICANYLDiscontinued
TERBUTALINE SULFATE 5MG · TABLET · ORAL
BRICANYLDiscontinued
TERBUTALINE SULFATE 2.5MG · TABLET · ORAL
Approval history
2007-12-07Labeling · Supplement 22AP
2007-12-07Efficacy · Supplement 20AP
2007-12-07Labeling · Supplement 35 · standardAP
2007-12-07Efficacy · Supplement 19AP
1997-12-24Manufacturing (CMC) · Supplement 33 · standardAP
1997-10-08Efficacy · Supplement 36 · unknownAP
1991-05-03Manufacturing (CMC) · Supplement 31 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 30 · standardAP
1988-02-03Labeling · Supplement 32AP
1986-07-15Manufacturing (CMC) · Supplement 27 · standardAP
1986-07-10Labeling · Supplement 28AP
1986-02-22Labeling · Supplement 24AP
1986-02-22Manufacturing (CMC) · Supplement 23 · standardAP
1985-06-27Labeling · Supplement 25AP
1984-04-30Manufacturing (CMC) · Supplement 26 · standardAP
1978-09-13Manufacturing (CMC) · Supplement 21 · standardAP
1977-06-22Manufacturing (CMC) · Supplement 18 · standardAP
1976-06-30Labeling · Supplement 14AP
1976-06-30Labeling · Supplement 13AP
1976-06-24Manufacturing (CMC) · Supplement 16 · standardAP
1976-06-24Manufacturing (CMC) · Supplement 12 · standardAP
1976-06-24Manufacturing (CMC) · Supplement 15 · standardAP
1976-01-13Labeling · Supplement 11AP
1975-12-10Manufacturing (CMC) · Supplement 10 · standardAP
1975-12-10Manufacturing (CMC) · Supplement 7 · standardAP
1975-11-04Manufacturing (CMC) · Supplement 8 · standardAP
1975-11-04Labeling · Supplement 6AP
1975-11-04Labeling · Supplement 9AP
1975-11-04Labeling · Supplement 5AP
1975-07-21Manufacturing (CMC) · Supplement 4 · standardAP
1975-07-21Manufacturing (CMC) · Supplement 3 · standardAP
1975-06-18Labeling · Supplement 2AP
1975-06-18Manufacturing (CMC) · Supplement 1 · standardAP
1975-04-22Type 3 - New Dosage Form · Original · standardAP
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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