PFIZER INC FDA Approval NDA 020895

NDA 020895

PFIZER INC

FDA Drug Application

Application #020895

Documents

Letter1998-03-27
Letter2002-09-19
Letter2006-07-03
Letter2008-02-27
Letter2007-10-22
Letter2008-08-13
Letter2008-08-13
Letter2010-01-15
Letter2011-02-04
Letter2014-03-11
Letter2015-09-17
Label1998-03-27
Label2002-09-19
Label2002-09-19
Label2006-06-28
Label2005-07-08
Label2006-10-11
Label2008-02-26
Label2010-01-20
Label2015-09-23
Review2009-04-13
Review2008-02-19
Other Important Information from FDA2007-10-30
Letter2002-09-19
Letter2002-09-19
Letter2005-07-15
Letter2006-10-13
Letter2014-03-11
Letter2015-03-27
Label2002-09-19
Label2007-10-18
Label2011-01-31
Label2014-03-11
Label2014-03-11
Label2015-03-27
Review2008-02-19
Review2008-02-19
Label2017-08-17
Letter2017-08-22
Label2017-12-14
Letter2017-12-15
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Pediatric Amendment 21900-01-01
Pediatric Amendment 31900-01-01
Pediatric Amendment 41900-01-01
Pediatric Amendment 51900-01-01
Pediatric Amendment 61900-01-01

Application Sponsors

NDA 020895PFIZER INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 25MG BASE1VIAGRASILDENAFIL CITRATE
002TABLET;ORALEQ 50MG BASE1VIAGRASILDENAFIL CITRATE
003TABLET;ORALEQ 100MG BASE1VIAGRASILDENAFIL CITRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1998-03-27PRIORITY
LABELING; LabelingSUPPL2AP1998-08-13STANDARD
LABELING; LabelingSUPPL3AP1998-11-24STANDARD
LABELING; LabelingSUPPL4AP1998-12-22STANDARD
LABELING; LabelingSUPPL5AP2000-01-21STANDARD
LABELING; LabelingSUPPL6AP1999-06-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-02-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1999-11-16PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-01-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-03-16PRIORITY
LABELING; LabelingSUPPL11AP2002-09-19STANDARD
LABELING; LabelingSUPPL12AP2002-01-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-08-24PRIORITY
LABELING; LabelingSUPPL15AP2002-09-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-08-24PRIORITY
EFFICACY; EfficacySUPPL18AP2002-09-19STANDARD
LABELING; LabelingSUPPL20AP2006-06-26STANDARD
LABELING; LabelingSUPPL21AP2005-07-08STANDARD
LABELING; LabelingSUPPL23AP2006-10-06STANDARD
LABELING; LabelingSUPPL26AP2008-02-25STANDARD
LABELING; LabelingSUPPL27AP2007-10-18STANDARD
LABELING; LabelingSUPPL28AP2008-08-06STANDARD
LABELING; LabelingSUPPL29AP2008-08-06STANDARD
LABELING; LabelingSUPPL33AP2010-01-11STANDARD
LABELING; LabelingSUPPL36AP2011-01-31STANDARD
LABELING; LabelingSUPPL39AP2014-03-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2015-02-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2014-03-25PRIORITY
EFFICACY; EfficacySUPPL42AP2014-03-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP2015-01-26PRIORITY
LABELING; LabelingSUPPL44AP2015-03-26STANDARD
LABELING; LabelingSUPPL45AP2015-09-16STANDARD
LABELING; LabelingSUPPL48AP2017-12-14STANDARD
LABELING; LabelingSUPPL49AP2017-08-17STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL14Null0
SUPPL16Null0
SUPPL33Null7
SUPPL36Null6
SUPPL39Null7
SUPPL40Null0
SUPPL41Null0
SUPPL42Null15
SUPPL43Null0
SUPPL44Null15
SUPPL45Null15
SUPPL48Null7
SUPPL49Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20895
            [companyName] => UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIAGRA","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VIAGRA","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VIAGRA","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/14\/2017","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020895s048lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2017","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020895s049lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2015","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020895s045lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2015","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020895s044lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2014","submission":"SUPPL-42","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/20895s039s042lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2014","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/20895s039s042lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020895s036lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2010","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020895s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2008","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020895s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2007","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020895s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2006","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020895s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2006","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020895s20lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2005","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020895s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2002","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20895s11s15s18lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2002","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20895s11s15s18lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2002","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20895s11s15s18lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/viagralabel2.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIAGRA","submission":"SILDENAFIL CITRATE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIAGRA","submission":"SILDENAFIL CITRATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIAGRA","submission":"SILDENAFIL CITRATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-14
        )

)
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