APPLICATION
ANDA202359
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-28
LATEST ACTION
2021-03-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
COLISTIMETHATE SODIUMPrescription
COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-03-15Labeling · Supplement 4 · standardAP
2016-02-10Labeling · Supplement 2 · standardAP
2012-09-28OriginalAP
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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