Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022401
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription AB Yes No
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription AB Yes No
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription AB Yes No
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG 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
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
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

TWYNSTA

TABLET;ORAL; EQ 5MG BASE;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 10MG BASE;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 5MG BASE;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 10MG BASE;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

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