NDA 200603

SUNOVION PHARMS INC

FDA Drug Application

Application #200603

Documents

• Letter: 2010-11-03
• Letter: 2010-12-28
• Letter: 2011-12-13
• Letter: 2011-12-13
• Letter: 2013-07-02
• Letter: 2013-01-24
• Label: 2010-10-29
• Label: 2012-05-01
• Label: 2012-05-01
• Label: 2013-07-09
• Label: 2013-09-24
• Review: 2015-11-17
• Other Important Information from FDA: 2011-12-22
• Letter: 2012-04-27
• Letter: 2012-04-27
• Letter: 2013-01-24
• Letter: 2013-07-02
• Letter: 2013-09-05
• Label: 2010-12-23
• Label: 2011-12-13
• Label: 2011-12-13
• Label: 2013-01-23
• Label: 2013-07-09
• Label: 2013-01-23
• Label: 2013-07-17
• Review: 2010-12-03
• Review: 2015-11-17
• Summary Review: 2011-02-17
• Label: 2017-01-11
• Letter: 2017-01-18
• Letter: 2017-01-31
• Letter: 2017-01-31
• Label: 2017-02-01
• Label: 2017-02-01
• Label: 2017-02-27
• Letter: 2017-03-02
• Label: 2017-09-26
• Letter: 2017-09-26
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 2018-01-22
• Pediatric Statistical Review: 2018-01-22
• Pediatric Written Request: 2016-12-20
• Pediatric Written Request: 2016-12-20
• Label: 2018-03-08
• Letter: 2018-03-15
• Letter: 2019-12-05
• Label: 2019-12-06
• Medication Guide: 2019-12-06
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01

Application Sponsors

NDA 200603

SUNOVION PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	40MG	1	LATUDA	LURASIDONE HYDROCHLORIDE
002	TABLET;ORAL	80MG	1	LATUDA	LURASIDONE HYDROCHLORIDE
003	TABLET;ORAL	20MG	1	LATUDA	LURASIDONE HYDROCHLORIDE
004	TABLET;ORAL	120MG	1	LATUDA	LURASIDONE HYDROCHLORIDE
005	TABLET;ORAL	60MG	1	LATUDA	LURASIDONE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2010-10-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2011-12-07	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2012-04-26	STANDARD
LABELING; Labeling	SUPPL	6	AP	2011-12-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-04-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2013-01-22	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2013-06-28	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2013-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-06-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2013-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-05-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2013-07-12	STANDARD
LABELING; Labeling	SUPPL	16	AP	2013-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2014-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-01-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2015-07-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	2017-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2016-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2016-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2016-12-20	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	2017-01-27	PRIORITY
EFFICACY; Efficacy	SUPPL	27	AP	2017-01-27	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2017-02-23	901 REQUIRED
EFFICACY; Efficacy	SUPPL	29	AP	2018-03-05	STANDARD
LABELING; Labeling	SUPPL	30	AP	2017-09-25	STANDARD
LABELING; Labeling	SUPPL	35	AP	2019-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	15
SUPPL	5	Null	6
SUPPL	6	Null	0
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	6
SUPPL	12	Null	0
SUPPL	13	Null	6
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	15
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	6
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	8
SUPPL	27	Null	6
SUPPL	28	Null	6
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	35	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

SUNOVION PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200603
            [companyName] => SUNOVION PHARMS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/200603s035lbl.pdf#page=62"]
            [products] => [{"drugName":"LATUDA","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LATUDA","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LATUDA","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LATUDA","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LATUDA","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200603s035lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-29","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200603s029lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2017","submission":"SUPPL-27","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s26s27lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2017","submission":"SUPPL-26","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s26s27lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603Org1s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2013","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603s015lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/28\/2013","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603lbls10s11.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603lbls10s11.pdf\"}]","notes":""},{"actionDate":"01\/22\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603s009s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603s009s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200603s005s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200603s005s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2011","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200603s004s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200603s004s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200603s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200603s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/28\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200603s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200603s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200603Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200603Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200603s035lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200603Orig1s035ltr.pdf\"}]","notes":">"},{"actionDate":"09\/25\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200603Orig1s030ltr.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2018","submission":"SUPPL-29","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200603s029lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200603Orig1s029ltr.pdf\"}]","notes":">"},{"actionDate":"02\/23\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s028lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200603Orig1s028ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-27","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s26s27lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200603Orig1s26,s27ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-26","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s26s27lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200603Orig1s26,s27ltr.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2016","submission":"SUPPL-25","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/08\/2016","submission":"SUPPL-24","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/29\/2016","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/11\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200603s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200603Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2015","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/05\/2015","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/28\/2014","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/03\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603Org1s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200603Org1s016ltr.pdf\"}]","notes":">"},{"actionDate":"07\/12\/2013","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603s015lbl.pdf\"}]","notes":">"},{"actionDate":"05\/21\/2014","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/22\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603s009s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200603Orig1s009,s013ltr.pdf\"}]","notes":">"},{"actionDate":"06\/13\/2013","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2013","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603lbls10s11.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200603Orig1s010,s011ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/200603Orig1s011.pdf\"}]","notes":">"},{"actionDate":"06\/28\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603lbls10s11.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200603Orig1s010,s011ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/200603Orig1s010.pdf\"}]","notes":">"},{"actionDate":"01\/22\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200603s009s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200603Orig1s009,s013ltr.pdf\"}]","notes":">"},{"actionDate":"04\/26\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200603s005s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200603s005,s007ltr.pdf\"}]","notes":">"},{"actionDate":"12\/07\/2011","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200603s004s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200603s004,s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/26\/2012","submission":"SUPPL-5","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200603s005s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200603s005,s007ltr.pdf\"}]","notes":">"},{"actionDate":"12\/07\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200603s004s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200603s004,s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/10\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200603s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200603s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-04
        )

)