Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202276
Company: METUCHEN PHARMS
Company: METUCHEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STENDRA | AVANAFIL | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
STENDRA | AVANAFIL | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
STENDRA | AVANAFIL | 200MG | 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 |
---|---|---|---|---|---|---|---|
04/27/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202276Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/18/2022 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202276s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202276Orig1s020ltr.pdf | |
08/03/2018 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202276s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202276Orig1s018ltr.pdf | |
10/10/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202276Orig1s017ltr.pdf | |
08/16/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202276Orig1s016ltr.pdf | |
06/15/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/16/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s013ltr.pdf | |
11/02/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/03/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/13/2015 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s010ltr.pdf | |
02/09/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/20/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/2014 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s006ltr.pdf | |
09/17/2014 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s005ltr.pdf | |
07/10/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/06/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/18/2022 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202276s020lbl.pdf | |
08/03/2018 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202276s018lbl.pdf | |
10/10/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s017lbl.pdf | |
08/16/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202276s016lbl.pdf | |
09/16/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s013lbl.pdf | |
05/13/2015 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s010lbl.pdf | |
09/17/2014 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s005lbl.pdf | |
04/29/2014 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s006lbl.pdf | |
10/31/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s001lbl.pdf | |
04/27/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf |
STENDRA
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AVANAFIL | AVANAFIL | 50MG | TABLET;ORAL | Prescription | No | AB | 209266 | HETERO LABS LTD V |
STENDRA | AVANAFIL | 50MG | TABLET;ORAL | Prescription | Yes | AB | 202276 | METUCHEN PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AVANAFIL | AVANAFIL | 100MG | TABLET;ORAL | Prescription | No | AB | 209266 | HETERO LABS LTD V |
STENDRA | AVANAFIL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 202276 | METUCHEN PHARMS |
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AVANAFIL | AVANAFIL | 200MG | TABLET;ORAL | Prescription | No | AB | 209266 | HETERO LABS LTD V |
STENDRA | AVANAFIL | 200MG | TABLET;ORAL | Prescription | Yes | AB | 202276 | METUCHEN PHARMS |