APPLICATION
ANDA063100
TYPE
ANDA
ORIGINAL APPROVAL
1992-01-30
LATEST ACTION
2023-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TOBRAMYCIN SULFATEDiscontinued
TOBRAMYCIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 25 · standardAP
2023-01-18Labeling · Supplement 23 · standardAP
2023-01-18Labeling · Supplement 22 · standardAP
2023-01-11Labeling · Supplement 19 · standardAP
2010-12-09Labeling · Supplement 9AP
2000-08-09Labeling · Supplement 7AP
1999-07-13Labeling · Supplement 6AP
1995-06-02Manufacturing (CMC) · Supplement 5AP
1994-04-04Manufacturing (CMC) · Supplement 3AP
1993-12-16Labeling · Supplement 4AP
1993-03-10Manufacturing (CMC) · Supplement 1AP
1993-03-02Labeling · Supplement 2AP
1992-01-30OriginalAP
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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