BLA 125160

UCB INC

FDA Drug Application

Application #125160

Documents

• Letter: 2008-04-30
• Letter: 2009-12-02
• Letter: 2010-11-04
• Letter: 2012-08-06
• Letter: 2011-09-13
• Letter: 2012-10-10
• Letter: 2013-10-01
• Letter: 2013-10-18
• Letter: 2016-05-04
• Letter: 2016-02-04
• Label: 2008-05-08
• Label: 2009-12-12
• Label: 2010-08-10
• Label: 2012-04-20
• Label: 2012-11-16
• Label: 2013-10-01
• Label: 2013-10-22
• Label: 2016-02-11
• Review: 2008-07-07
• Review: 2013-09-09
• Other Important Information from FDA: 2008-09-04
• Letter: 2009-01-30
• Letter: 2010-08-02
• Letter: 2012-04-23
• Letter: 2012-08-31
• Letter: 2012-11-16
• Letter: 2012-10-10
• Letter: 2015-10-21
• Label: 2012-08-03
• Label: 2012-08-31
• Label: 2012-10-09
• Label: 2012-10-09
• Label: 2016-04-29
• Label: 2015-10-22
• Summary Review: 2008-07-14
• Label: 2017-01-05
• Letter: 2017-01-05
• Label: 2018-03-28
• Letter: 2018-03-28
• Label: 2018-05-29
• Medication Guide: 2018-05-29
• Letter: 2018-05-29
• Letter: 2019-02-28
• Label: 2019-02-28
• Medication Guide: 2019-02-27
• Letter: 2019-03-29
• Label: 2019-04-02
• Medication Guide: 2019-04-02
• Review: 2019-06-03
• Letter: 2019-09-09
• Label: 2019-09-09
• Medication Guide: 2019-09-09
• Review: 2019-10-31
• Review: 2021-01-07
• Letter: 2022-12-23
• Label: 2022-12-27
• Medication Guide: 2022-12-27

Application Sponsors

BLA 125160

UCB INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

200MG

0

CIMZIA

CERTOLIZUMAB PEGOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-04-22	STANDARD
LABELING; Labeling	SUPPL	36	AP	2008-12-22	STANDARD
LABELING; Labeling	SUPPL	38	AP	2008-12-31	STANDARD
EFFICACY; Efficacy	SUPPL	80	AP	2009-05-13	STANDARD
LABELING; Labeling	SUPPL	92	AP	2009-11-18	STANDARD
LABELING; Labeling	SUPPL	111	AP	2010-07-29	STANDARD
LABELING; Labeling	SUPPL	122	AP	2010-12-21	STANDARD
LABELING; Labeling	SUPPL	126	AP	2010-10-06	STANDARD
LABELING; Labeling	SUPPL	142	AP	2012-08-02	STANDARD
LABELING; Labeling	SUPPL	152	AP	2011-09-14	STANDARD
LABELING; Labeling	SUPPL	155	AP	2011-07-26	STANDARD
LABELING; Labeling	SUPPL	157	AP	2011-09-07	STANDARD
EFFICACY; Efficacy	SUPPL	174	AP	2012-04-17	STANDARD
LABELING; Labeling	SUPPL	180	AP	2012-08-29	STANDARD
LABELING; Labeling	SUPPL	186	AP	2012-10-05	STANDARD
LABELING; Labeling	SUPPL	189	AP	2012-11-15	STANDARD
LABELING; Labeling	SUPPL	192	AP	2012-10-05	STANDARD
EFFICACY; Efficacy	SUPPL	213	AP	2013-09-27	STANDARD
EFFICACY; Efficacy	SUPPL	215	AP	2013-10-17	STANDARD
EFFICACY; Efficacy	SUPPL	237	AP	2019-03-28	STANDARD
LABELING; Labeling	SUPPL	241	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	264	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	266	AP	2016-02-26	STANDARD
LABELING; Labeling	SUPPL	268	AP	2016-02-03	STANDARD
LABELING; Labeling	SUPPL	270	AP	2017-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	279	AP	2018-06-14	N/A
LABELING; Labeling	SUPPL	281	AP	2018-03-20	STANDARD
EFFICACY; Efficacy	SUPPL	283	AP	2018-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	286	AP	2018-03-16	N/A
LABELING; Labeling	SUPPL	289	AP	2019-02-27	STANDARD
LABELING; Labeling	SUPPL	293	AP	2019-09-06	STANDARD
EFFICACY; Efficacy	SUPPL	305	AP	2022-12-22	STANDARD

Submissions Property Types

SUPPL	38	Null	7
SUPPL	92	Null	7
SUPPL	155	Null	7
SUPPL	237	Null	15
SUPPL	241	Null	6
SUPPL	264	Null	7
SUPPL	266	Null	7
SUPPL	268	Null	7
SUPPL	270	Null	7
SUPPL	279	Null	6
SUPPL	281	Null	7
SUPPL	283	Null	6
SUPPL	286	Null	15
SUPPL	289	Null	15
SUPPL	293	Null	6
SUPPL	305	Null	6

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125160
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125160s293lbl.pdf#page=41"]
            [products] => [{"drugName":"CIMZIA","activeIngredients":"CERTOLIZUMAB PEGOL","strength":"200MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-293","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s293lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2019","submission":"SUPPL-237","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s237lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2019","submission":"SUPPL-289","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s289lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2019","submission":"SUPPL-289","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s289lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2019","submission":"SUPPL-289","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s289lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2018","submission":"SUPPL-283","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125160s283lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2018","submission":"SUPPL-281","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125160s281lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-270","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125160s270lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2016","submission":"SUPPL-241","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125160s241lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2016","submission":"SUPPL-268","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125160s268lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2015","submission":"SUPPL-264","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125160s264lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2013","submission":"SUPPL-215","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125160s215lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2013","submission":"SUPPL-213","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125160s213lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2012","submission":"SUPPL-189","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s189lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2012","submission":"SUPPL-192","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s186s192lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2012","submission":"SUPPL-186","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s186s192lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2012","submission":"SUPPL-180","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s180lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2012","submission":"SUPPL-142","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s0142lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2012","submission":"SUPPL-174","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s0174lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2010","submission":"SUPPL-111","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/125160s111lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2009","submission":"SUPPL-92","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125160s092lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125160s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/22\/2008","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125160s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125160s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/125160s000TOC2.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/125160s000_SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-293","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s293lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125160Orig1s293ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2019","submission":"SUPPL-289","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s289lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125160Orig1s289ltr.pdf\"}]","notes":">"},{"actionDate":"03\/16\/2018","submission":"SUPPL-286","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/24\/2018","submission":"SUPPL-283","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125160s283lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125160Orig1s283ltr.pdf\"}]","notes":">"},{"actionDate":"03\/20\/2018","submission":"SUPPL-281","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125160s281lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125160Origs281ltr.pdf\"}]","notes":">"},{"actionDate":"06\/14\/2018","submission":"SUPPL-279","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2017","submission":"SUPPL-270","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125160s270lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125160Orig1s270ltr.pdf\"}]","notes":">"},{"actionDate":"02\/03\/2016","submission":"SUPPL-268","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125160s268lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125160Orig1s268ltr.pdf\"}]","notes":">"},{"actionDate":"02\/26\/2016","submission":"SUPPL-266","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2015","submission":"SUPPL-264","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125160s264lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125160Orig1s264ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2016","submission":"SUPPL-241","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125160s241lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125160Orig1s241ltr.pdf\"}]","notes":">"},{"actionDate":"03\/28\/2019","submission":"SUPPL-237","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125160s237lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125160Orig1s237ltr.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2013","submission":"SUPPL-215","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125160s215lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125160Orig1s215ltr_replace.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125160Orig1s215.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2013","submission":"SUPPL-213","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125160s213lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125160Orig1s213ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/125160Orig1s213.pdf\"}]","notes":">"},{"actionDate":"10\/05\/2012","submission":"SUPPL-192","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s186s192lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125160Orig1s186,s192ltr.pdf\"}]","notes":">"},{"actionDate":"11\/15\/2012","submission":"SUPPL-189","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s189lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125160Orig1s189ltr.pdf\"}]","notes":">"},{"actionDate":"10\/05\/2012","submission":"SUPPL-186","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s186s192lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125160Orig1s186,s192ltr.pdf\"}]","notes":">"},{"actionDate":"08\/29\/2012","submission":"SUPPL-180","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s180lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125160Orig1s180ltr.pdf\"}]","notes":">"},{"actionDate":"04\/17\/2012","submission":"SUPPL-174","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s0174lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125160s0174ltr.pdf\"}]","notes":">"},{"actionDate":"09\/07\/2011","submission":"SUPPL-157","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125160s157ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/26\/2011","submission":"SUPPL-155","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/14\/2011","submission":"SUPPL-152","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/02\/2012","submission":"SUPPL-142","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125160s0142lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125160Orig1s142ltr.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2010","submission":"SUPPL-126","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125160s126ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2010","submission":"SUPPL-122","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/29\/2010","submission":"SUPPL-111","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/125160s111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125160s111ltr.pdf\"}]","notes":">"},{"actionDate":"11\/18\/2009","submission":"SUPPL-92","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125160s092lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125160s092ltr.pdf\"}]","notes":">"},{"actionDate":"05\/13\/2009","submission":"SUPPL-80","supplementCategories":"Supplement","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2009\\\/125160Orig1s080.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/31\/2008","submission":"SUPPL-38","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125160s038ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/22\/2008","submission":"SUPPL-36","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-06
        )

)