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FDA ANDA · ANDA062938

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Sponsor: PADAGIS US

APPLICATION
ANDA062938
TYPE
ANDA
ORIGINAL APPROVAL
1989-07-31
LATEST ACTION
2020-02-10
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-02-10Labeling · Supplement 16 · standardAP
2014-08-01Manufacturing (CMC) · Supplement 14AP
2002-07-18Manufacturing (CMC) · Supplement 6AP
2002-07-18Manufacturing (CMC) · Supplement 7AP
1996-03-07Manufacturing (CMC) · Supplement 5AP
1995-10-27Manufacturing (CMC) · Supplement 4AP
1995-10-27Manufacturing (CMC) · Supplement 3AP
1995-06-12Manufacturing (CMC) · Supplement 2AP
1995-06-12Manufacturing (CMC) · Supplement 1AP
1989-07-31OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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