APPLICATION
ANDA061578
TYPE
ANDA
ORIGINAL APPROVAL
1972-01-05
LATEST ACTION
2001-12-06
ROUTE
FOR RX COMPOUNDING
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
POLY-RXDiscontinued
POLYMYXIN B SULFATE 100,000,000 UNITS/BOT · POWDER · FOR RX COMPOUNDING
Approval history
2001-12-06Manufacturing (CMC) · Supplement 5AP
2001-04-27Manufacturing (CMC) · Supplement 4AP
1999-11-15Manufacturing (CMC) · Supplement 3AP
1994-07-29Manufacturing (CMC) · Supplement 1AP
1994-06-20Manufacturing (CMC) · Supplement 2AP
1972-01-05OriginalAP
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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