APPLICATION
ANDA065407
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-11
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 21 · standardAP
2023-01-18Labeling · Supplement 12 · standardAP
2023-01-18Labeling · Supplement 13 · standardAP
2014-10-24Labeling · Supplement 5 · standardAP
2014-04-23Labeling · Supplement 4 · standardAP
2008-03-11OriginalAP
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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