NDA 210296

BANNER LIFE SCIENCES LLC

FDA Drug Application

Application #210296

Documents

• Letter: 2020-04-29
• Label: 2020-04-29
• Review: 2020-11-30
• Letter: 2023-01-13
• Label: 2023-01-13

Application Sponsors

NDA 210296

BANNER LIFE SCIENCES LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED RELEASE;ORAL

95MG

0

MONOMETHYL FUMARATE

MONOMETHYL FUMARATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2020-04-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2023-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	6

CDER Filings

BANNER LIFE SCIENCES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210296
            [companyName] => BANNER LIFE SCIENCES
            [docInserts] => ["",""]
            [products] => [{"drugName":"BAFIERTAM","activeIngredients":"MONOMETHYL FUMARATE","strength":"95MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/28\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210296s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210296s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210296Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-28
        )

)