APPLICATION
ANDA205179
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-16
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 10 · standardAP
2023-01-17Labeling · Supplement 3 · standardAP
2023-01-17Labeling · Supplement 4 · standardAP
2014-09-16UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.