APPLICATION
NDA022407
TYPE
NDA
ORIGINAL APPROVAL
2013-06-21
LATEST ACTION
2013-06-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VIBATIVPrescription
TELAVANCIN 750MG · INJECTABLE · INJECTION
VIBATIVPrescription
TELAVANCIN 250MG · INJECTABLE · INJECTION
Approval history
2013-06-21Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Review ↗AP
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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