APPLICATION
ANDA065013
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-17
LATEST ACTION
2023-08-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOBRAMYCIN SULFATEPrescription
TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2023-08-29Labeling · Supplement 17 · standardAP
2023-02-10Labeling · Supplement 16 · standardAP
2013-10-07Manufacturing (CMC) · Supplement 10AP
2013-08-16Labeling · Supplement 12 · standardAP
2012-11-09Labeling · Supplement 11 · standardAP
2012-10-31Labeling · Supplement 9AP
2010-10-18Labeling · Supplement 8AP
2002-12-09Manufacturing (CMC) · Supplement 2AP
2001-08-17OriginalAP
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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