APPLICATION
NDA017849
TYPE
NDA
ORIGINAL APPROVAL
1976-05-17
LATEST ACTION
2011-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BRETHINE · ReferencePrescription
TERBUTALINE SULFATE 2.5MG · TABLET · ORAL
BRETHINE · ReferencePrescription
TERBUTALINE SULFATE 5MG · TABLET · ORAL
Approval history
2011-04-08Labeling · Supplement 40 · 901 requiredAP
2002-05-28Manufacturing (CMC) · Supplement 37 · standardAP
2002-03-04Manufacturing (CMC) · Supplement 38 · standardAP
1999-04-23Manufacturing (CMC) · Supplement 36 · standardAP
1999-02-08Manufacturing (CMC) · Supplement 34 · standardAP
1999-02-02Labeling · Supplement 32 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 33 · standardAP
1997-07-07Manufacturing (CMC) · Supplement 30 · standardAP
1997-02-25Manufacturing (CMC) · Supplement 31 · standardAP
1996-02-23Manufacturing (CMC) · Supplement 29 · standardAP
1995-12-18Manufacturing (CMC) · Supplement 28 · standardAP
1995-11-14Manufacturing (CMC) · Supplement 27 · standardAP
1995-03-24Manufacturing (CMC) · Supplement 26 · standardAP
1993-02-09Manufacturing (CMC) · Supplement 24 · standardAP
1992-07-16Manufacturing (CMC) · Supplement 25 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 21 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 18 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 20 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 17 · standardAP
1982-03-22Manufacturing (CMC) · Supplement 16 · standardAP
1981-06-06Manufacturing (CMC) · Supplement 15 · standardAP
1980-11-05Manufacturing (CMC) · Supplement 14 · standardAP
1980-06-25Manufacturing (CMC) · Supplement 12 · standardAP
1980-06-04Manufacturing (CMC) · Supplement 11 · standardAP
1980-02-13Manufacturing (CMC) · Supplement 13 · standardAP
1979-05-24Labeling · Supplement 7AP
1979-04-03Manufacturing (CMC) · Supplement 8 · standardAP
1979-04-03Manufacturing (CMC) · Supplement 10 · standardAP
1979-04-03Manufacturing (CMC) · Supplement 9 · standardAP
1979-01-03Manufacturing (CMC) · Supplement 5 · standardAP
1979-01-03Manufacturing (CMC) · Supplement 6 · standardAP
1977-03-08Manufacturing (CMC) · Supplement 3 · standardAP
1977-03-08Manufacturing (CMC) · Supplement 1 · standardAP
1977-03-08Manufacturing (CMC) · Supplement 2 · standardAP
1976-05-17Type 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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