APPLICATION
ANDA062339
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-30
LATEST ACTION
1995-08-04
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
STATROLDiscontinued
NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 16,250 UNITS/ML · SOLUTION/DROPS · OPHTHALMIC
Approval history
1995-08-04Manufacturing (CMC) · Supplement 7AP
1993-08-18Labeling · Supplement 6AP
1993-04-14Labeling · Supplement 5AP
1984-11-30OriginalAP
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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