APPLICATION
ANDA060582
TYPE
ANDA
ORIGINAL APPROVAL
1968-07-03
LATEST ACTION
2006-09-13
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
NEOSPORINDiscontinued
GRAMICIDIN 0.025MG/ML, NEOMYCIN SULFATE EQ 1.75MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OPHTHALMIC
Approval history
2006-09-13Labeling · Supplement 9AP
1999-07-23Manufacturing (CMC) · Supplement 8AP
1995-10-27Labeling · Supplement 6AP
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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