APPLICATION
ANDA202766
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-15
LATEST ACTION
2025-07-03
ROUTE
INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, OPHTHALMIC, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
POLYMYXIN B SULFATEPrescription
POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-07-03Labeling · Supplement 11 · standardAP
2024-06-12Labeling · Supplement 6 · standardAP
2014-01-15UNKNOWN · OriginalAP
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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