Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 022110
Company: CUMBERLAND

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

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