Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020591
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1MG;240MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/1996 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2019 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020591s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020591Orig1s030ltr.pdf
08/02/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020591s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020591Orig1s029ltr.pdf
07/12/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s027ltr.pdf
01/29/2016 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s026ltr.pdf
12/24/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020591Orig1s025ltr.pdf
01/05/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/20/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/12/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020591s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020591Orig1s021ltr.pdf
01/23/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf
11/14/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s019ltr.pdf
09/14/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s018ltr.pdf
03/05/2009 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020591s016ltr.pdf
08/29/2011 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s012ltr.pdf
02/29/2008 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020591s011ltr.pdf
08/20/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/14/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/01/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/03/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/22/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2019 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020591s030lbl.pdf
08/02/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020591s029lbl.pdf
07/12/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s027lbl.pdf
01/29/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s026lbl.pdf
12/24/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf
09/12/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020591s021lbl.pdf
01/23/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf
11/14/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s019lbl.pdf
09/14/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s018lbl.pdf
08/29/2011 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf

TARKA

TABLET, EXTENDED RELEASE;ORAL; 2MG;180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020591 ABBVIE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079135 GLENMARK GENERICS

TABLET, EXTENDED RELEASE;ORAL; 4MG;240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020591 ABBVIE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079135 GLENMARK GENERICS

TABLET, EXTENDED RELEASE;ORAL; 2MG;240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020591 ABBVIE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079135 GLENMARK GENERICS

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