APPLICATION
ANDA062945
TYPE
ANDA
ORIGINAL APPROVAL
1989-08-09
LATEST ACTION
2023-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TOBRAMYCIN SULFATEDiscontinued
TOBRAMYCIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
TOBRAMYCIN SULFATEDiscontinued
TOBRAMYCIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 22 · standardAP
2023-02-10Labeling · Supplement 20 · standardAP
2023-02-10Labeling · Supplement 19 · standardAP
2023-02-10Labeling · Supplement 21 · standardAP
2000-12-08Manufacturing (CMC) · Supplement 17AP
2000-06-20Labeling · Supplement 16AP
2000-04-28Manufacturing (CMC) · Supplement 15AP
1998-11-03Labeling · Supplement 14AP
1996-07-11Manufacturing (CMC) · Supplement 13AP
1995-11-01Manufacturing (CMC) · Supplement 12AP
1995-10-27Manufacturing (CMC) · Supplement 11AP
1995-04-10Manufacturing (CMC) · Supplement 8AP
1994-06-17Labeling · Supplement 10AP
1994-03-15Manufacturing (CMC) · Supplement 9AP
1992-04-29Manufacturing (CMC) · Supplement 6AP
1992-04-13Labeling · Supplement 5AP
1992-04-13Manufacturing (CMC) · Supplement 1AP
1992-03-05Manufacturing (CMC) · Supplement 7AP
1991-05-31Manufacturing (CMC) · Supplement 4AP
1991-05-10Manufacturing (CMC) · Supplement 3AP
1989-08-09OriginalAP
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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