Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020738
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEVETEN EPROSARTAN MESYLATE EQ 300MG BASE TABLET;ORAL Discontinued None No No
TEVETEN EPROSARTAN MESYLATE EQ 400MG BASE TABLET;ORAL Discontinued None Yes No
TEVETEN EPROSARTAN MESYLATE EQ 600MG BASE TABLET;ORAL Discontinued None 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
12/22/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020738_tevetan_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020738s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020738Orig1s029ltr.pdf
09/12/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738Orig1s028ltr.pdf
01/19/2012 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf
05/03/2011 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020738s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020738s026ltr.pdf
10/16/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf
10/29/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/15/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/08/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/05/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/04/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/02/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/27/1999 SUPPL-4 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20738-s004_teveten.pdf
05/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/30/1998 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1998 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_PRNTLBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020738s001_teveten_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020738s029lbl.pdf
09/12/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s028lbl.pdf
01/19/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s027lbl.pdf
05/03/2011 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020738s026lbl.pdf
10/28/1998 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20738S001_TEVETEN_PRNTLBL.PDF

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