Documents
Application Sponsors
Marketing Status
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001 | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LEUSTATIN | CLADRIBINE |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TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-02-26 | STANDARD Withdrawn FR Effective 11/03/2016 |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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":"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
)
)