Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021268
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEVETEN HCT EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600MG;12.5MG TABLET;ORAL Discontinued None No No
TEVETEN HCT EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600MG;25MG TABLET;ORAL Discontinued None No 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
11/01/2001 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_Teveten.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021268Orig1s019ltr.pdf
09/12/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021268Orig1s018ltr.pdf
01/19/2012 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf
05/19/2011 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf
05/19/2011 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf
07/11/2005 SUPPL-9 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021268s009ltr.pdf
07/07/2003 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21268scm006ltr.pdf
10/16/2003 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf
09/27/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf
09/12/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf
01/19/2012 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf
05/19/2011 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf
05/19/2011 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf
11/01/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf

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