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FDA ANDA · ANDA065187

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA065187
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-28
LATEST ACTION
2005-10-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINPrescription
GRAMICIDIN 0.025MG/ML, NEOMYCIN SULFATE EQ 1.75MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OPHTHALMIC

Approval history

2005-10-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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