NDA 020229

JANSSEN PHARMS

FDA Drug Application

Application #020229

Documents

• Label: 2012-08-03
• Letter: 2012-08-03
• Letter: 2006-07-03
• Letter: 2002-08-20
• Letter: 2002-08-20
• Letter: 2002-08-22

Application Sponsors

NDA 020229

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

LEUSTATIN

CLADRIBINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-02-26	STANDARD Withdrawn FR Effective 11/03/2016
LABELING; Labeling	SUPPL	4	AP	2002-08-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2002-08-20	STANDARD
LABELING; Labeling	SUPPL	21	AP	2002-08-22	STANDARD
LABELING; Labeling	SUPPL	30	AP	2006-06-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	2012-08-02	STANDARD

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20229
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUSTATIN","activeIngredients":"CLADRIBINE","strength":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/02\/2012","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020229s034lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEUSTATIN","submission":"CLADRIBINE","actionType":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-08-02
        )

)