Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020895
Company: PFIZER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIAGRA SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription None Yes No
VIAGRA SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription None Yes No
VIAGRA SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription None 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
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
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

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