APPLICATION
ANDA090110
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-29
LATEST ACTION
2025-07-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
POLYMYXIN B SULFATEDiscontinued
POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-07-03Labeling · Supplement 4 · standardAP
2012-12-03Labeling · Supplement 1AP
2011-06-29OriginalAP
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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