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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022110
Company: CUMBERLAND

REMS

Medication Guide

Summary Review

Products on NDA 022110

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIBATIV	TELAVANCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL	POWDER;INTRAVENOUS	Discontinued	None	Yes	No
VIBATIV	TELAVANCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022110s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022110s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022110s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022110Orig1s016ltr.pdf
02/20/2020	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022110s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022110Orig1s015ltr.pdf
05/24/2017	SUPPL-14	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022110Orig1s014ltr.pdf
03/23/2016	SUPPL-13	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s013ltr.pdf
05/06/2016	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s012ltr.pdf
12/03/2014	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s011ltr.pdf
11/12/2014	SUPPL-10	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s010ltr.pdf
03/13/2014	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s009lbl.pdf
12/12/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/07/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s007lbl.pdf
05/31/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/01/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/21/2013	SUPPL-3	REMS-Assessment	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf
07/27/2011	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022110s002ltr_corrected.pdf

Labels for NDA 022110

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022110s016lbl.pdf
02/20/2020	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022110s015lbl.pdf
02/20/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022110s015lbl.pdf
05/06/2016	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf
12/03/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s011lbl.pdf
03/13/2014	SUPPL-9	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s009lbl.pdf
02/07/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s007lbl.pdf
06/21/2013	SUPPL-3	REMS-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf
09/11/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022110s000lbl.pdf

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