NDA 022372

BRAINTREE LABS

FDA Drug Application

Application #022372

Documents

• Letter: 2011-07-12
• Label: 2012-11-02
• Summary Review: 2011-09-16
• Letter: 2010-08-10
• Letter: 2012-11-06
• Label: 2010-08-10
• Review: 2011-09-16
• Medication Guide: 2010-08-10
• Label: 2020-08-06
• Medication Guide: 2020-08-06
• Letter: 2020-08-06

Application Sponsors

NDA 022372

BRAINTREE LABS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

1

SUPREP BOWEL PREP KIT

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2010-08-05	STANDARD
REMS; REMS	SUPPL	3	AP	2011-07-06	N/A
LABELING; Labeling	SUPPL	4	AP	2012-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2012-07-24	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2020-08-05	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	0
SUPPL	13	Null	6

TE Codes

001

Prescription

AA

CDER Filings

BRAINTREE LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22372
            [companyName] => BRAINTREE LABS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022372s013lbl.pdf#page=13"]
            [products] => [{"drugName":"SUPREP BOWEL PREP KIT","activeIngredients":"MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE","strength":"1.6GM\/BOT;3.13GM\/BOT;17.5GM\/BOT","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/05\/2020","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022372Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022372s004lbledt.pdf\"}]","notes":""},{"actionDate":"11\/06\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022372s004lbledt.pdf\"}]","notes":""},{"actionDate":"08\/05\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022372s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SUPREP BOWEL PREP KIT","submission":"MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE","actionType":"1.6GM\/BOT;3.13GM\/BOT;17.5GM\/BOT","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-05
        )

)