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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021894
Company: BAUSCH

Medication Guide

Summary Review

Products on NDA 021894

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021894

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	REMS-Proposal, Labeling-Medication Guide	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

Labels for NDA 021894

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	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021894s005lbl.pdf
05/04/2011	SUPPL-5	Labeling-Medication Guide	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

Therapeutic Equivalents for NDA 021894

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	213316	ADAPTIS
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	206093	APOTEX
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	208826	BIONPHARMA
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	210544	CHARTWELL RX
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	209284	DR REDDYS
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	204574	HETERO LABS LTD V
TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	No	AB	207682	MYLAN
XENAZINE	TETRABENAZINE	12.5MG	TABLET;ORAL	Prescription	Yes	AB	021894	BAUSCH

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	213316	ADAPTIS
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	206093	APOTEX
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	208826	BIONPHARMA
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	210544	CHARTWELL RX
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	209284	DR REDDYS
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	204574	HETERO LABS LTD V
TETRABENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	No	AB	207682	MYLAN
XENAZINE	TETRABENAZINE	25MG	TABLET;ORAL	Prescription	Yes	AB	021894	BAUSCH

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