APPLICATION
ANDA060716
TYPE
ANDA
ORIGINAL APPROVAL
1964-06-29
LATEST ACTION
2025-07-03
ROUTE
INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, OPHTHALMIC, 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 27 · standardAP
2019-03-29Manufacturing (CMC) · Supplement 26AP
2002-05-15Manufacturing (CMC) · Supplement 15AP
2000-11-28Manufacturing (CMC) · Supplement 14AP
2000-11-28Manufacturing (CMC) · Supplement 12AP
2000-11-28Manufacturing (CMC) · Supplement 13AP
1996-08-26Manufacturing (CMC) · Supplement 9AP
1996-08-26Manufacturing (CMC) · Supplement 8AP
1996-08-26Labeling · Supplement 10AP
1996-05-31Manufacturing (CMC) · Supplement 11AP
1992-04-17Manufacturing (CMC) · Supplement 7AP
1989-08-03Manufacturing (CMC) · Supplement 6AP
1964-06-29OriginalAP
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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