APPLICATION
ANDA064216
TYPE
ANDA
ORIGINAL APPROVAL
1999-02-26
LATEST ACTION
2018-06-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
COLISTIMETHATE SODIUMDiscontinued
COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2018-06-06Manufacturing (CMC) · Supplement 15 · unknownAP
2011-06-27Labeling · Supplement 11AP
2006-07-03Labeling · Supplement 8AP
2006-02-07Labeling · Supplement 6AP
2002-02-01Manufacturing (CMC) · Supplement 4AP
2001-07-13Labeling · Supplement 3AP
2000-05-01Manufacturing (CMC) · Supplement 1AP
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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