APPLICATION
ANDA063111
TYPE
ANDA
ORIGINAL APPROVAL
1991-04-30
LATEST ACTION
2023-02-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOBRAMYCIN SULFATEPrescription
TOBRAMYCIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 22 · standardAP
2015-09-21Labeling · Supplement 18 · standardAP
2005-04-07Labeling · Supplement 10AP
2005-04-07Labeling · Supplement 11AP
2004-04-27Labeling · Supplement 9AP
2002-10-25Manufacturing (CMC) · Supplement 8AP
1999-02-16Manufacturing (CMC) · Supplement 7AP
1996-10-03Manufacturing (CMC) · Supplement 5AP
1993-12-10Labeling · Supplement 3AP
1993-04-02Manufacturing (CMC) · Supplement 2AP
1991-10-30Labeling · Supplement 1AP
1991-04-30OriginalAP
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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