APPLICATION
ANDA062544
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-29
LATEST ACTION
2001-04-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
DEXACIDINDiscontinued
DEXAMETHASONE 0.1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2001-04-19Manufacturing (CMC) · Supplement 9AP
1998-02-11Manufacturing (CMC) · Supplement 6AP
1995-04-24Manufacturing (CMC) · Supplement 4AP
1994-06-10Manufacturing (CMC) · Supplement 5AP
1993-08-17Labeling · Supplement 3AP
1993-01-04Manufacturing (CMC) · Supplement 2AP
1984-10-29OriginalAP
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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