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FDA NDA · NDA213895

VANCOMYCIN

Sponsor: HIKMA

APPLICATION
NDA213895
TYPE
NDA
ORIGINAL APPROVAL
2021-08-26
LATEST ACTION
2021-08-26
ROUTE
INTRAVENOUS, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

VANCOMYCIN · ReferenceDiscontinued
VANCOMYCIN 5GM/100ML (50MG/ML) · SOLUTION · INTRAVENOUS, ORAL

Approval history

2021-08-26Type 5 - New Formulation or New Manufacturer · Original · priorityLetterAP
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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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