← FDA DRUG APPROVALS

FDA ANDA · ANDA065088

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA065088
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-06
LATEST ACTION
2017-03-10
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCDiscontinued
BACITRACIN ZINC 400 UNITS/GM, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2017-03-10Manufacturing (CMC) · Supplement 8 · unknownAP
2004-02-06Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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