← FDA DRUG APPROVALS

FDA ANDA · ANDA065213

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA065213
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-25
LATEST ACTION
2017-03-10
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEDiscontinued
BACITRACIN ZINC 400 UNITS/GM, HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC

Approval history

2017-03-10Manufacturing (CMC) · Supplement 4 · unknownAP
2012-07-25OriginalAP
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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