NDA 016295

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #016295

Documents

• Letter: 2001-04-04
• Letter: 2003-07-06
• Letter: 2004-03-02
• Letter: 2006-09-20
• Letter: 2012-01-30
• Letter: 2012-01-30
• Letter: 2015-07-20
• Letter: 2015-07-20
• Letter: 2016-03-25
• Label: 2003-07-08
• Label: 2004-04-05
• Label: 2012-01-31
• Label: 2015-07-17
• Letter: 2010-05-12
• Label: 2006-09-20
• Label: 2010-05-17
• Label: 2012-01-31
• Label: 2015-07-17
• Label: 2016-03-28
• Label: 2016-03-28
• Review: 2004-04-14
• Label: 2017-12-19
• Label: 2017-12-19
• Medication Guide: 2017-12-19
• Medication Guide: 2017-12-19
• Letter: 2017-12-20
• Letter: 2017-12-20
• Letter: 2019-07-23
• Label: 2019-07-23
• Medication Guide: 2019-07-23
• Label: 2019-12-19
• Letter: 2019-12-23
• Letter: 2021-02-10
• Label: 2021-02-16
• Label: 2021-08-06
• Letter: 2021-08-06
• Medication Guide: 2022-01-14
• Letter: 2022-01-18

Application Sponsors

NDA 016295

BRISTOL MYERS SQUIBB

Marketing Status

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

Application Products

001	CAPSULE;ORAL	500MG	1	HYDREA	HYDROXYUREA
002	CAPSULE;ORAL	200MG	1	DROXIA	HYDROXYUREA
003	CAPSULE;ORAL	300MG	1	DROXIA	HYDROXYUREA
004	CAPSULE;ORAL	400MG	1	DROXIA	HYDROXYUREA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1967-12-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1977-05-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1980-02-19	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1996-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-03-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-07-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-03-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-05-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-08-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-09-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-07-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1993-03-09	PRIORITY
LABELING; Labeling	SUPPL	23	AP	1996-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-10-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1996-11-25	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1999-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1997-04-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1997-05-23	PRIORITY
EFFICACY; Efficacy	SUPPL	29	AP	1998-02-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-02-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-11-10	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2000-01-12	STANDARD
LABELING; Labeling	SUPPL	34	AP	2001-04-04	STANDARD
LABELING; Labeling	SUPPL	35	AP	2001-02-20	STANDARD
EFFICACY; Efficacy	SUPPL	36	AP	2003-06-26	STANDARD
LABELING; Labeling	SUPPL	37	AP	2004-02-19	STANDARD
LABELING; Labeling	SUPPL	39	AP	2006-09-19	STANDARD
LABELING; Labeling	SUPPL	40	AP	2010-05-07	STANDARD
LABELING; Labeling	SUPPL	41	AP	2012-01-26	STANDARD
LABELING; Labeling	SUPPL	42	AP	2012-01-26	UNKNOWN
LABELING; Labeling	SUPPL	45	AP	2015-07-16	STANDARD
LABELING; Labeling	SUPPL	46	AP	2015-07-16	STANDARD
LABELING; Labeling	SUPPL	47	AP	2016-03-23	STANDARD
LABELING; Labeling	SUPPL	48	AP	2016-03-23	STANDARD
LABELING; Labeling	SUPPL	49	AP	2017-12-18	STANDARD
LABELING; Labeling	SUPPL	50	AP	2017-12-18	STANDARD
LABELING; Labeling	SUPPL	51	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	52	AP	2019-12-18	STANDARD
LABELING; Labeling	SUPPL	54	AP	2021-02-09	STANDARD
LABELING; Labeling	SUPPL	55	AP	2021-08-05	STANDARD
LABELING; Labeling	SUPPL	56	AP	2022-01-13	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	40	Null	7
SUPPL	41	Null	15
SUPPL	42	Null	6
SUPPL	45	Null	7
SUPPL	46	Null	7
SUPPL	47	Null	15
SUPPL	48	Null	6
SUPPL	49	Null	6
SUPPL	50	Null	7
SUPPL	51	Null	7
SUPPL	52	Null	15
SUPPL	54	Null	7
SUPPL	55	Null	15
SUPPL	56	Null	6

TE Codes

001

Prescription

AB

CDER Filings

BRISTOL MYERS SQUIBB

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(
    [0] => Array
        (
            [ApplNo] => 16295
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/016295s051lbl.pdf#page=27"]
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            [labels] => [{"actionDate":"12\/18\/2019","submission":"SUPPL-52","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/016295s052lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2019","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/016295s051lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2017","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016295s049s050lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2017","submission":"SUPPL-50","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016295s049s050lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2017","submission":"SUPPL-49","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016295s049s050lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2017","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016295s049s050lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2016","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/016295Orig1s047,s048Lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2016","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/016295Orig1s047,s048Lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2015","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/016295s046lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2015","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/016295s045lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2012","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/016295s041s042lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2012","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/016295s041s042lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2010","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/016295s040lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2006","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/016295s039s036lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2004","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/16295slr037_hydrea_lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2003","submission":"SUPPL-36","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/16295se2-036_droxia_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DROXIA","submission":"HYDROXYUREA","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DROXIA","submission":"HYDROXYUREA","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DROXIA","submission":"HYDROXYUREA","actionType":"400MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HYDREA","submission":"HYDROXYUREA","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-18
        )

)