PF PRISM CV FDA Approval NDA 022488

NDA 022488

PF PRISM CV

FDA Drug Application

Application #022488

Documents

Letter2011-04-29
Letter2012-04-18
Letter2013-03-01
Label2010-01-08
Label2011-04-29
Label2011-04-29
Label2013-12-24
Label2016-03-15
Review2010-06-22
Summary Review2010-06-22
Letter2010-01-06
Letter2011-04-29
Letter2011-04-29
Letter2011-08-26
Letter2011-06-29
Letter2013-12-26
Letter2016-03-11
Label2011-04-29
Label2011-08-30
Label2011-07-07
Label2013-03-15
Label2016-12-22
Letter2016-12-23
Label2018-05-04
Medication Guide2018-05-04
Letter2018-05-08
Label2019-05-24
Medication Guide2019-05-24
Letter2019-05-24
Letter2020-04-06
Label2020-04-09
Pediatric Statistical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric CDTL Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 022488PF PRISM CV

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL20MG/ML1LYRICAPREGABALIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2010-01-04STANDARD
LABELING; LabelingSUPPL2AP2011-04-26STANDARD
LABELING; LabelingSUPPL3AP2011-04-26STANDARD
LABELING; LabelingSUPPL4AP2011-08-24UNKNOWN
LABELING; LabelingSUPPL5AP2011-06-20STANDARD
LABELING; LabelingSUPPL6AP2012-04-16STANDARD
EFFICACY; EfficacySUPPL7AP2013-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-12-23N/A
LABELING; LabelingSUPPL10AP2016-03-09STANDARD
EFFICACY; EfficacySUPPL11AP2016-12-22STANDARD
EFFICACY; EfficacySUPPL13AP2018-05-03PRIORITY
EFFICACY; EfficacySUPPL14AP2019-05-23PRIORITY
LABELING; LabelingSUPPL17AP2020-04-03STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null6
SUPPL3Null0
SUPPL4Null15
SUPPL5Null6
SUPPL6Null6
SUPPL7Null7
SUPPL8Null7
SUPPL10Null7
SUPPL11Null7
SUPPL13Null7
SUPPL14Null8
SUPPL17Null7

TE Codes

001PrescriptionAA

CDER Filings

UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22488
            [companyName] => UPJOHN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021446s036,022488s014lbl.pdf#page=56"]
            [products] => [{"drugName":"LYRICA","activeIngredients":"PREGABALIN","strength":"20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/03\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"05\/23\/2019","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021446s036,022488s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2018","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021446s035,022488s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021446s032,022488s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021446s030,022488s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021446s029,022488s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2013","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022488s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022488-s004-0211446s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s026,022488s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-1","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2011","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021446s023s024,022488s001s002s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022488,021446s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LYRICA","submission":"PREGABALIN","actionType":"20MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-03
        )

)
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