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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022401
Company: BOEHRINGER INGELHEIM

Summary Review

Products on NDA 022401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TWYNSTA	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2009	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022401s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022401_twynsta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/22401s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022401s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022401Orig1s019ltr.pdf
01/13/2016	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022401s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022401Orig1s018ltr.pdf
11/19/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/12/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022401Orig1s016ltr.pdf
12/11/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/14/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s012ltr.pdf
03/29/2012	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s011ltr.pdf
11/14/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s010ltr.pdf
10/19/2012	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf
10/19/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf
06/06/2011	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s005ltr.pdf
01/18/2012	SUPPL-4	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s004ltr.pdf
07/27/2010	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022401s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022401s002ltr.pdf

Labels for NDA 022401

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022401s019lbl.pdf
01/13/2016	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022401s018lbl.pdf
12/12/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf
11/14/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s012lbl.pdf
10/19/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf
10/19/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf
03/29/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf
01/18/2012	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf
11/14/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf
06/06/2011	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s005lbl.pdf
07/27/2010	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022401s002lbl.pdf
10/16/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf

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