Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022110
Company: CUMBERLAND PHARMS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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