Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021894
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription AB Yes No
XENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription AB 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
08/15/2008 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021894lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021894s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021894s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021894Orig1s013ltr.pdf
08/25/2015 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021894Orig1s012ltr.pdf
06/03/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021894s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021894Orig1s010ltr.pdf
08/02/2013 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021894Orig1s009ltr.pdf
08/17/2012 SUPPL-7 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021894Orig1s007ltr.pdf
05/04/2011 SUPPL-5 Labeling-Medication Guide, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021894s005ltr.pdf
07/06/2011 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021894s004ltr.pdf
12/01/2009 SUPPL-2 Labeling, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021894s001s002ltr.pdf
12/01/2009 SUPPL-1 Labeling, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021894s001s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/13/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf
06/03/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021894s010lbl.pdf
07/06/2011 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s004lbl.pdf
05/04/2011 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005lbl.pdf
05/04/2011 SUPPL-5 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005lbl.pdf
08/15/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021894lbl.pdf

XENAZINE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 207682 APICORE US
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 204574 HETERO LABS LTD V
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 206129 SUN PHARMA GLOBAL
XENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription Yes AB 021894 VALEANT PHARMS NORTH

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 206686 ACTAVIS LABS FL INC
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 207682 APICORE US
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 204574 HETERO LABS LTD V
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 206129 SUN PHARMA GLOBAL
XENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription Yes AB 021894 VALEANT PHARMS NORTH

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