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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020738
Company: ABBVIE

Other Important Information from FDA

Products on NDA 020738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEVETEN	EPROSARTAN MESYLATE	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No
TEVETEN	EPROSARTAN MESYLATE	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TEVETEN	EPROSARTAN MESYLATE	EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 020738

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

Labels for NDA 020738

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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