NDA 021430

CELGENE

FDA Drug Application

Application #021430

Documents

• Letter: 2006-05-26
• Other Important Information from FDA: 2006-06-06
• Other: 2012-03-09
• Label: 2006-05-26
• Review: 2008-10-03

Application Sponsors

NDA 021430

CELGENE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE; ORAL	50MG	0	THALOMID	THALIDOMIDE
002	CAPSULE; ORAL	100MG	0	THALOMID	THALIDOMIDE
003	CAPSULE; ORAL	200MG	0	THALOMID	THALIDOMIDE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2006-05-25

STANDARD

Submissions Property Types

ORIG

1

Null

41

CDER Filings

CELGENE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21430
            [companyName] => CELGENE
            [docInserts] => ["",""]
            [products] => [{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"50MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"100MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"200MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/25\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021430lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"50MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"100MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"200MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-05-25
        )

)