NDA 203595

BRAINTREE LABS

FDA Drug Application

Application #203595

Documents

• Letter: 2013-01-23
• Label: 2013-01-23
• Review: 2014-01-24
• Medication Guide: 2013-02-05
• Summary Review: 2014-01-24

Application Sponsors

NDA 203595

BRAINTREE LABS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

SUCLEAR

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2013-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-08-15	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	0

CDER Filings

BRAINTREE LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203595
            [companyName] => BRAINTREE LABS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM337734.pdf"]
            [products] => [{"drugName":"SUCLEAR","activeIngredients":"MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE","strength":"1.6GM\/BOT,3.13GM\/BOT,17.5GM\/BOT,N\/A,N\/A,N\/A,N\/A;N\/A,N\/A,N\/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/18\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203595s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203595s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203595Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203595Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203595Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/15\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/15\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2013-08-15
        )

)