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FDA NDA · NDA022110

VIBATIV

telavancin hydrochloride

Sponsor: APOTEX

APPLICATION
NDA022110
TYPE
NDA
ORIGINAL APPROVAL
2009-09-11
LATEST ACTION
2020-07-07
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued, Prescription

Products

VIBATIV · ReferenceDiscontinued
TELAVANCIN HYDROCHLORIDE EQ 250MG BASE/VIAL · POWDER · INTRAVENOUS
VIBATIV · ReferencePrescription
TELAVANCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2020-07-07Labeling · Supplement 16 · standard — Letter ↗AP
2020-02-20Labeling · Supplement 15 · standard — Letter ↗AP
2017-05-24REMS · Supplement 14 — Letter ↗AP
2016-05-06Efficacy · Supplement 12 · standard — Letter ↗AP
2016-03-23REMS · Supplement 13 — Letter ↗AP
2014-12-03Labeling · Supplement 11 · standard — Letter ↗AP
2014-11-12REMS · Supplement 10 — Letter ↗AP
2014-03-13Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2014-02-07Labeling · Supplement 7 · standard — Label ↗AP
2013-12-12Manufacturing (CMC) · Supplement 8 · standardAP
2013-06-21REMS · Supplement 3 — Letter ↗AP
2013-05-31Manufacturing (CMC) · Supplement 6 · standardAP
2013-02-01Manufacturing (CMC) · Supplement 4 · standardAP
2011-07-27REMS · Supplement 2 — Letter ↗AP
2009-09-11Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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