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FDA ANDA · ANDA062721

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Sponsor: ALCON PHARMS LTD

APPLICATION
ANDA062721
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-17
LATEST ACTION
1999-06-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SUSPENSION/DROPS · OPHTHALMIC

Approval history

1999-06-16Manufacturing (CMC) · Supplement 15AP
1999-02-19Manufacturing (CMC) · Supplement 13AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1998-10-07Manufacturing (CMC) · Supplement 12AP
1998-08-25Labeling · Supplement 9AP
1998-05-07Manufacturing (CMC) · Supplement 10AP
1996-04-16Manufacturing (CMC) · Supplement 8AP
1995-03-27Manufacturing (CMC) · Supplement 7AP
1994-09-30Labeling · Supplement 6AP
1993-10-14Labeling · Supplement 5AP
1991-10-31Manufacturing (CMC) · Supplement 4AP
1989-01-12Manufacturing (CMC) · Supplement 3AP
1986-11-17OriginalAP
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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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