NDA 213135

BRAINTREE LABS

FDA Drug Application

Application #213135

Documents

• Label: 2020-11-10
• Medication Guide: 2020-11-12
• Letter: 2020-11-12
• Review: 2021-03-15
• Letter: 2022-02-01
• Label: 2022-02-01
• Medication Guide: 2022-02-01

Application Sponsors

NDA 213135

BRAINTREE LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1.479G;0.225G;0.188G

2

SUTAB

SODIUM SULFATE;MAGNESIUM SULFATE;POTASSIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-01-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

BRAINTREE LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213135
            [companyName] => BRAINTREE LABS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/213135s000lbl.pdf#page=14"]
            [products] => [{"drugName":"SUTAB (COPACKAGED)","activeIngredients":"MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE","strength":"0.225GM;0.188GM;1.479GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/10\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213135s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213135s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213135Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-10
        )

)