Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020895
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIAGRA | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| VIAGRA | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| VIAGRA | SILDENAFIL CITRATE | EQ 100MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 03/27/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagralabel2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20895ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/17/2017 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020895Orig1s049ltr.pdf | |
| 12/14/2017 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020895Orig1s048ltr.pdf | |
| 09/16/2015 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s045ltr.pdf | |
| 03/26/2015 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s044ltr.pdf | |
| 01/26/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2014 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042ltr.pdf | |
| 03/25/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2014 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042ltr.pdf | |
| 01/31/2011 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020895s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020895s036ltr.pdf | |
| 01/11/2010 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020895s033ltr.pdf | |
| 08/06/2008 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s028, s029ltr.pdf |
| 08/06/2008 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s028, s029ltr.pdf |
| 10/18/2007 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020895s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020895s027ltr.pdf | |
| 02/25/2008 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020895s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020895s026ltr.pdf | |
| 10/06/2006 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s023ltr.pdf | |
| 07/08/2005 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020895s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020895s021ltr.pdf | |
| 06/26/2006 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s020ltr.pdf | |
| 09/19/2002 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-018,slr011,015ltr.pdf | |
| 08/24/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/2002 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-018,slr011,015ltr.pdf | |
| 08/24/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/19/2002 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20895se8-018,slr011,015ltr.pdf | |
| 03/16/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S003_VIAGRA.pdf |
| 08/13/1998 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S002_VIAGRA.pdf |
| 05/04/1998 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S001_VIAGRA.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/14/2017 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s048lbl.pdf | |
| 08/17/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s049lbl.pdf | |
| 09/16/2015 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s045lbl.pdf | |
| 03/26/2015 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020895s044lbl.pdf | |
| 03/11/2014 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf | |
| 03/11/2014 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf | |
| 01/31/2011 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020895s036lbl.pdf | |
| 01/11/2010 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf | |
| 02/25/2008 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020895s026lbl.pdf | |
| 10/18/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020895s027lbl.pdf | |
| 10/06/2006 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s023lbl.pdf | |
| 06/26/2006 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020895s20lbl.pdf | |
| 07/08/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020895s021lbl.pdf | |
| 09/19/2002 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf | |
| 09/19/2002 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf | |
| 09/19/2002 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20895s11s15s18lbl.pdf | |
| 03/27/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagralabel2.pdf |
VIAGRA
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 206401 | AJANTA PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202023 | AMNEAL PHARMS NY |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 207178 | APPCO |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 203962 | AUROBINDO PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 218045 | CADILA PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 212051 | CHARTWELL RX |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202659 | HETERO LABS LTD V |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202255 | MACLEODS PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 201171 | MYLAN |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 216383 | NOVITIUM PHARMA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 208494 | REYOUNG |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 204882 | RUBICON |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 213032 | SUNSHINE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077342 | TEVA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 091448 | TORRENT |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 209302 | UMEDICA |
| VIAGRA | SILDENAFIL CITRATE | EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020895 | VIATRIS |
TABLET;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 206401 | AJANTA PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202023 | AMNEAL PHARMS NY |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 207178 | APPCO |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 203962 | AUROBINDO PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 218045 | CADILA PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 212051 | CHARTWELL RX |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202659 | HETERO LABS LTD V |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202255 | MACLEODS PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 201171 | MYLAN |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 216383 | NOVITIUM PHARMA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 208494 | REYOUNG |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 204882 | RUBICON |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 213032 | SUNSHINE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077342 | TEVA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 091448 | TORRENT |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 209302 | UMEDICA |
| VIAGRA | SILDENAFIL CITRATE | EQ 50MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020895 | VIATRIS |
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 206401 | AJANTA PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202023 | AMNEAL PHARMS NY |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 207178 | APPCO |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 203962 | AUROBINDO PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 218045 | CADILA PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212051 | CHARTWELL RX |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202659 | HETERO LABS LTD V |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202255 | MACLEODS PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 201171 | MYLAN |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 216383 | NOVITIUM PHARMA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 208494 | REYOUNG |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 204882 | RUBICON |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 213032 | SUNSHINE |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077342 | TEVA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 091448 | TORRENT |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 209302 | UMEDICA |
| VIAGRA | SILDENAFIL CITRATE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020895 | VIATRIS |