Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200179
Company: BAYER HLTHCARE
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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