APPLICATION
ANDA062566
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-22
LATEST ACTION
1996-08-08
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
DEXACIDINDiscontinued
DEXAMETHASONE 0.1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC
Approval history
1996-08-08Manufacturing (CMC) · Supplement 6AP
1996-08-08Manufacturing (CMC) · Supplement 2AP
1996-07-03Manufacturing (CMC) · Supplement 4AP
1996-06-25Manufacturing (CMC) · Supplement 5AP
1995-12-15Manufacturing (CMC) · Supplement 3AP
1992-04-13Labeling · Supplement 1AP
1985-02-22OriginalAP
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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