APPLICATION
ANDA062664
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-08
LATEST ACTION
2006-05-23
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
NEOMYCIN AND POLYMYXIN B SULFATEDiscontinued
NEOMYCIN SULFATE EQ 40MG BASE/ML, POLYMYXIN B SULFATE 200,000 UNITS/ML · SOLUTION · IRRIGATION
Approval history
2006-05-23Labeling · Supplement 17AP
1999-02-19Manufacturing (CMC) · Supplement 12AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1996-12-04Manufacturing (CMC) · Supplement 10AP
1995-08-16Manufacturing (CMC) · Supplement 9AP
1992-01-29Manufacturing (CMC) · Supplement 8AP
1989-05-10Manufacturing (CMC) · Supplement 7AP
1986-04-08OriginalAP
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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