Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021400
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVITRA VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No
LEVITRA VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes No
LEVITRA VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription AB Yes No
LEVITRA VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/19/2003 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21400_levitra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21400ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-400_Levitra.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021400s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021400Orig1s020ltr.pdf
09/16/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/21400s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021400Orig1s019ltr.pdf
11/03/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/29/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021400Orig1s017ltr.pdf
08/02/2013 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021400s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021400Orig1s016ltr.pdf
11/22/2011 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021400s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021400s013ltr.pdf
05/15/2008 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021400s012ltr.pdf
03/19/2008 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021400s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021400s011ltr.pdf
10/18/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021400s010ltr.pdf
04/06/2007 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021400s008ltr.pdf
07/08/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021400s004ltr.pdf
05/13/2005 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021400s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021400s020lbl.pdf
09/16/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/21400s019lbl.pdf
04/29/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf
08/02/2013 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021400s016lbl.pdf
11/22/2011 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021400s013lbl.pdf
03/19/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021400s011lbl.pdf
10/18/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s010lbl.pdf
04/06/2007 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s008lbl.pdf
07/08/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s004lbl.pdf
05/13/2005 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s002lbl.pdf
08/19/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21400_levitra_lbl.pdf

LEVITRA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVITRA VARDENAFIL HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 021400 BAYER HLTHCARE

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