Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020738
Company: ABBVIE
Company: ABBVIE
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TEVETEN | EPROSARTAN MESYLATE | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
TEVETEN | EPROSARTAN MESYLATE | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TEVETEN | EPROSARTAN MESYLATE | EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
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 |