APPLICATION
NDA050477
TYPE
NDA
ORIGINAL APPROVAL
1975-06-11
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NEBCIN · ReferenceDiscontinued
TOBRAMYCIN SULFATE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 22 · standardAP
1999-03-04Manufacturing (CMC) · Supplement 23 · standardAP
1997-10-01Efficacy · Supplement 21 · standardAP
1997-05-13Labeling · Supplement 17 · standardAP
1997-04-03Manufacturing (CMC) · Supplement 20 · standardAP
1997-03-19Labeling · Supplement 18 · standardAP
1995-10-18Manufacturing (CMC) · Supplement 19 · standardAP
1993-04-01Labeling · Supplement 16AP
1992-08-06Labeling · Supplement 15AP
1991-10-28Labeling · Supplement 7AP
1991-10-28Manufacturing (CMC) · Supplement 8 · standardAP
1987-07-21Labeling · Supplement 6AP
1987-04-02Labeling · Supplement 5AP
1987-03-05Manufacturing (CMC) · Supplement 4 · standardAP
1985-11-04Labeling · Supplement 3AP
1984-09-28Manufacturing (CMC) · Supplement 2 · standardAP
1984-02-24Manufacturing (CMC) · Supplement 1 · standardAP
1980-05-28Manufacturing (CMC) · Supplement 14 · standardAP
1976-06-02Labeling · Supplement 13AP
1976-02-23Labeling · Supplement 12AP
1976-01-13Manufacturing (CMC) · Supplement 11 · standardAP
1975-09-03Efficacy · Supplement 10AP
1975-07-30Labeling · Supplement 9AP
1975-06-11Type 1 - New Molecular Entity · 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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