APPLICATION
ANDA205685
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-16
LATEST ACTION
2025-05-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOBRAMYCIN SULFATEPrescription
TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-05-30Labeling · Supplement 3 · standardAP
2023-02-10Labeling · Supplement 1 · 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.