APPLICATION
NDA018571
TYPE
NDA
ORIGINAL APPROVAL
1981-11-30
LATEST ACTION
2011-04-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRETHINE · ReferenceDiscontinued
TERBUTALINE SULFATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2011-04-08Labeling · Supplement 23 · 901 requiredAP
2002-01-25Manufacturing (CMC) · Supplement 17 · standardAP
2001-08-17Manufacturing (CMC) · Supplement 16 · standardAP
2000-03-21Labeling · Supplement 15 · standardAP
1998-12-11Labeling · Supplement 10 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 14 · standardAP
1998-09-17Manufacturing (CMC) · Supplement 13 · standardAP
1998-03-12Manufacturing (CMC) · Supplement 12 · standardAP
1997-11-19Manufacturing (CMC) · Supplement 9 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 11 · standardAP
1997-07-07Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-13Manufacturing (CMC) · Supplement 7 · standardAP
1995-07-05Manufacturing (CMC) · Supplement 6 · standardAP
1989-02-09Labeling · Supplement 2AP
1989-02-09Manufacturing (CMC) · Supplement 1 · standardAP
1984-08-17Manufacturing (CMC) · Supplement 3 · standardAP
1981-11-30Type 5 - New Formulation or New Manufacturer · 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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