Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200179
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STAXYN VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;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
06/17/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200179s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200179_staxyn_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200179Orig1s005ltr.pdf
08/02/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200179Orig1s004ltr.pdf
09/16/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200179s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200179Orig1s003ltr.pdf
04/29/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200179Orig1s002ltr.pdf
08/02/2013 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200179s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200179Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s005lbl.pdf
08/02/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200179s004lbl.pdf
09/16/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200179s003lbl.pdf
04/29/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf
08/02/2013 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200179s001lbl.pdf
06/17/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf

STAXYN

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STAXYN VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 200179 BAYER HLTHCARE
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 208324 ALEMBIC PHARMS LTD
VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205988 MACLEODS PHARMS LTD

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