NDA 209501

PF PRISM CV

FDA Drug Application

Application #209501

Documents

• Label: 2017-10-12
• Medication Guide: 2017-10-12
• Letter: 2017-10-12
• Review: 2018-10-26
• Letter: 2020-04-06
• Label: 2020-04-09

Application Sponsors

NDA 209501

PF PRISM CV

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	82.5MG	1	LYRICA CR	PREGABALIN
002	TABLET, EXTENDED RELEASE;ORAL	165MG	1	LYRICA CR	PREGABALIN
003	TABLET, EXTENDED RELEASE;ORAL	330MG	1	LYRICA CR	PREGABALIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-10-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-04-03	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209501
            [companyName] => PFIZER
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/209501s000lbl.pdf#page=29"]
            [products] => [{"drugName":"LYRICA CR","activeIngredients":"PREGABALIN","strength":"82.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"LYRICA CR","activeIngredients":"PREGABALIN","strength":"165MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"LYRICA CR","activeIngredients":"PREGABALIN","strength":"330MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209501s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209501s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209501s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209501Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209501Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209501s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209501Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-03
        )

)