NDA 211281

BRAINTREE LABS

FDA Drug Application

Application #211281

Documents

• Label: 2020-02-13
• Letter: 2020-02-13
• Review: 2020-03-18
• Letter: 2021-08-18
• Label: 2021-08-19

Application Sponsors

NDA 211281

BRAINTREE LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SOLUTION;ORAL	10GM	1	PIZENSY	LACTITOL
002	SOLUTION;ORAL	20G	2	PIZENSY	LACTITOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-02-12

STANDARD

Submissions Property Types

ORIG

1

Null

6

TE Codes

002

Prescription

TBD

CDER Filings

BRAINTREE LABS

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(
    [0] => Array
        (
            [ApplNo] => 211281
            [companyName] => BRAINTREE LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIZENSY","activeIngredients":"LACTITOL","strength":"10GM","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PIZENSY","activeIngredients":"LACTITOL","strength":"20G","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/12\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211281s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211281s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211281Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/211281Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-02-12
        )

)