NDA 022561

EMD SERONO INC

FDA Drug Application

Application #022561

Documents

• Label: 2019-04-05
• Medication Guide: 2019-04-01
• Letter: 2019-04-04
• Review: 2019-08-06
• Letter: 2022-09-20
• Label: 2022-09-20
• Medication Guide: 2022-09-20

Application Sponsors

NDA 022561

EMD SERONO INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

1

MAVENCLAD

CLADRIBINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-03-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-09-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	6

CDER Filings

EMD SERONO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22561
            [companyName] => EMD SERONO INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022561s000lbl.pdf#page=29"]
            [products] => [{"drugName":"MAVENCLAD","activeIngredients":"CLADRIBINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/29\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022561s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MAVENCLAD","submission":"CLADRIBINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-29
        )

)