APPLICATION
NDA050519
TYPE
NDA
ORIGINAL APPROVAL
1979-06-11
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NEBCIN · ReferenceDiscontinued
TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 23 · standardAP
1997-10-01Efficacy · Supplement 22 · standardAP
1997-03-19Labeling · Supplement 19 · standardAP
1997-01-02Manufacturing (CMC) · Supplement 21 · standardAP
1995-12-20Manufacturing (CMC) · Supplement 20 · standardAP
1993-04-01Labeling · Supplement 18AP
1992-08-06Labeling · Supplement 8AP
1991-10-28Labeling · Supplement 6AP
1985-11-04Labeling · Supplement 5AP
1985-05-20Manufacturing (CMC) · Supplement 4 · standardAP
1984-10-04Manufacturing (CMC) · Supplement 3 · standardAP
1983-08-04Manufacturing (CMC) · Supplement 2 · standardAP
1983-01-18Labeling · Supplement 1AP
1982-07-20Manufacturing (CMC) · Supplement 17 · standardAP
1982-06-09Labeling · Supplement 16AP
1981-10-02Labeling · Supplement 15AP
1981-09-30Labeling · Supplement 10AP
1981-08-28Manufacturing (CMC) · Supplement 14 · standardAP
1981-06-05Manufacturing (CMC) · Supplement 11 · standardAP
1981-05-29Labeling · Supplement 13AP
1981-03-06Labeling · Supplement 12AP
1980-09-18Manufacturing (CMC) · Supplement 9 · standardAP
1979-06-11Type 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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