NDA 020785

CELGENE

FDA Drug Application

Application #020785

Documents

• Letter: 1998-07-16
• Letter: 2001-09-05
• Letter: 2003-10-31
• Letter: 2006-05-26
• Letter: 2010-08-06
• Letter: 2013-02-12
• Letter: 2013-11-18
• Letter: 2014-06-23
• Letter: 2015-09-15
• Letter: 2015-10-29
• Label: 1998-07-16
• Label: 2001-09-05
• Label: 2003-01-17
• Label: 2003-10-31
• Label: 2003-10-31
• Label: 2006-05-26
• Label: 2012-02-06
• Review: 2006-09-06
• Review: 2007-07-27
• Review: 2007-07-27
• Other: 2010-08-16
• Letter: 2001-09-05
• Letter: 2003-01-17
• Letter: 2004-06-18
• Letter: 2003-10-31
• Letter: 2003-10-31
• Letter: 2004-03-10
• Letter: 2004-03-10
• Letter: 2007-01-16
• Letter: 2012-02-08
• Letter: 2012-02-08
• Letter: 2012-02-08
• Letter: 2015-08-10
• Letter: 2014-09-16
• Letter: 2015-12-02
• Letter: 2016-04-25
• Label: 2003-04-23
• Label: 2003-03-06
• Label: 2003-10-31
• Label: 2012-02-06
• Label: 2012-02-06
• Label: 2013-02-12
• Label: 2015-08-07
• Label: 2014-06-23
• Review: 2001-09-05
• Other Important Information from FDA: 2003-12-12
• Label: 2017-01-27
• Letter: 2017-01-31
• Letter: 2017-06-12
• Label: 2017-12-01
• Letter: 2017-12-01
• Letter: 2017-12-29
• Label: 2018-01-02
• Medication Guide: 2018-01-02
• Letter: 2019-06-10
• Label: 2019-06-10
• Medication Guide: 2019-06-10
• Letter: 2019-12-05
• Label: 2019-12-06
• Medication Guide: 2019-12-06
• Letter: 2021-03-01
• Label: 2021-03-02
• Letter: 2021-08-06

Application Sponsors

NDA 020785

CELGENE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	50MG	1	THALOMID	THALIDOMIDE
002	CAPSULE;ORAL	100MG	1	THALOMID	THALIDOMIDE
003	CAPSULE;ORAL	200MG	1	THALOMID	THALIDOMIDE
004	CAPSULE;ORAL	150MG	1	THALOMID	THALIDOMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-07-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-05-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-05-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-05-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-04-03	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2001-09-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2001-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-11-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-11-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-11-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2003-01-17	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2003-01-17	STANDARD
LABELING; Labeling	SUPPL	22	AP	2003-10-27	STANDARD
LABELING; Labeling	SUPPL	23	AP	2003-10-27	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-10-27	STANDARD
LABELING; Labeling	SUPPL	25	AP	2004-03-05	STANDARD
LABELING; Labeling	SUPPL	26	AP	2004-03-05	STANDARD
LABELING; Labeling	SUPPL	31	AP	2006-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2007-01-10	N/A
LABELING; Labeling	SUPPL	35	AP	2012-02-03	STANDARD
LABELING; Labeling	SUPPL	39	AP	2010-08-03	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2012-02-03	STANDARD
LABELING; Labeling	SUPPL	43	AP	2012-02-03	UNKNOWN
REMS; REMS	SUPPL	48	AP	2013-02-08	N/A
REMS; REMS	SUPPL	50	AP	2013-11-15	N/A
LABELING; Labeling	SUPPL	51	AP	2015-08-05	STANDARD
REMS; REMS	SUPPL	54	AP	2014-09-12	N/A
LABELING; Labeling	SUPPL	55	AP	2014-06-19	STANDARD
REMS; REMS	SUPPL	57	AP	2015-09-13	N/A
REMS; REMS	SUPPL	58	AP	2015-10-27	N/A
REMS; REMS	SUPPL	59	AP	2015-12-01	N/A
REMS; REMS	SUPPL	60	AP	2016-04-22	N/A
LABELING; Labeling	SUPPL	61	AP	2017-01-27	STANDARD
REMS; REMS	SUPPL	63	AP	2017-06-27	N/A
LABELING; Labeling	SUPPL	64	AP	2017-11-30	STANDARD
LABELING; Labeling	SUPPL	65	AP	2017-12-29	STANDARD
LABELING; Labeling	SUPPL	67	AP	2019-06-07	STANDARD
LABELING; Labeling	SUPPL	68	AP	2019-12-04	STANDARD
LABELING; Labeling	SUPPL	69	AP	2021-02-25	STANDARD
REMS; REMS	SUPPL	70	AP	2021-08-05	N/A

Submissions Property Types

ORIG	1	Null	41
SUPPL	3	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	15	Null	14
SUPPL	16	Null	14
SUPPL	17	Null	14
SUPPL	20	Null	14
SUPPL	31	Null	41
SUPPL	35	Null	7
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	43	Null	7
SUPPL	48	Null	7
SUPPL	50	Null	7
SUPPL	51	Null	7
SUPPL	54	Null	6
SUPPL	55	Null	6
SUPPL	57	Null	6
SUPPL	58	Null	6
SUPPL	59	Null	7
SUPPL	60	Null	15
SUPPL	61	Null	6
SUPPL	63	Null	15
SUPPL	64	Null	6
SUPPL	65	Null	6
SUPPL	67	Null	6
SUPPL	68	Null	6
SUPPL	69	Null	7
SUPPL	70	Null	7

CDER Filings

CELGENE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20785
            [companyName] => CELGENE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020785s068lbl.pdf#page=23"]
            [products] => [{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"THALOMID","activeIngredients":"THALIDOMIDE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020785s068lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2019","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020785s067lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2017","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020785s065lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020785s051lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020785s055lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2013","submission":"SUPPL-48","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020785s048lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2013","submission":"SUPPL-48","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020785s048lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020785s035s040s043lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-40","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020785s035s040s043lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020785s035s040s043lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2006","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20785s12s14lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2001","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20785s12s14lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20785lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"THALOMID","submission":"THALIDOMIDE","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-04
        )

)