PF PRISM CV FDA Approval NDA 021110

Application #021110

Documents

Letter	2003-01-23
Letter	2002-08-22
Letter	2003-04-18
Letter	2003-01-23
Letter	2005-07-08
Letter	2005-10-14
Letter	2006-06-06
Letter	2007-01-16
Letter	2007-02-12
Letter	2007-10-22
Letter	2008-03-10
Letter	2009-02-03
Letter	2009-11-10
Letter	2010-04-28
Letter	2010-12-07
Letter	2010-07-08
Letter	2010-12-07
Letter	2011-06-09
Letter	2012-12-11
Letter	2013-03-08
Label	2003-04-11
Label	2003-01-23
Label	2003-01-23
Label	2003-03-21
Label	2003-03-28
Label	2005-07-07
Label	2005-10-14
Label	2006-06-06
Label	2007-01-16
Label	2006-10-23
Label	2007-01-16
Label	2007-10-22
Label	2009-10-14
Label	2010-02-04
Label	2010-05-03
Label	2010-08-27
Label	2013-03-08
Label	2015-06-01
Label	2015-03-09
Review	2001-10-11
Letter	2000-08-25
Letter	2003-01-23
Letter	2003-01-23
Letter	2003-01-23
Letter	2004-06-14
Letter	2003-03-28
Letter	2003-10-02
Letter	2004-03-02
Letter	2004-07-21
Letter	2005-03-14
Letter	2005-07-08
Letter	2005-10-14
Letter	2006-06-06
Letter	2007-01-25
Letter	2007-05-09
Letter	2008-01-18
Letter	2008-03-07
Letter	2009-11-10
Letter	2010-02-01
Letter	2010-04-28
Letter	2010-11-24
Letter	2011-07-13
Letter	2013-09-17
Letter	2015-05-29
Letter	2015-03-10
Letter	2015-11-09
Label	2000-08-25
Label	2003-01-23
Label	2003-01-23
Label	2003-01-23
Label	2003-01-31
Label	2003-10-10
Label	2004-04-05
Label	2004-07-21
Label	2005-03-14
Label	2005-07-07
Label	2005-10-14
Label	2006-06-06
Label	2007-05-07
Label	2008-01-18
Label	2009-02-04
Label	2009-10-01
Label	2010-05-03
Label	2010-11-23
Label	2010-11-23
Label	2010-11-04
Label	2012-12-14
Label	2013-09-17
Label	2015-11-12
Review	2009-09-14
Label	2017-04-12
Label	2018-01-16
Letter	2018-01-17
Letter	2018-05-24
Label	2018-05-25
Medication Guide	2018-05-25
Label	2019-04-08
Medication Guide	2019-04-08
Letter	2019-04-09
Letter	2019-07-16
Medication Guide	2019-07-16
Label	2019-07-16
Letter	2020-01-03
Label	2020-01-06
Medication Guide	2020-01-06
Letter	2021-08-10
Label	2021-10-26
Medication Guide	2021-10-26
Letter	2022-08-23
Letter	2022-08-23
Medication Guide	2022-08-23
Label	2022-08-23
Label	2022-08-23

Application Sponsors

NDA 021110

PF PRISM CV

Marketing Status

Prescription	001
Prescription	002
Discontinued	003
Prescription	004

Application Products

001	TABLET;ORAL	1MG	1	RAPAMUNE	SIROLIMUS
002	TABLET;ORAL	2MG	1	RAPAMUNE	SIROLIMUS
003	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	RAPAMUNE	SIROLIMUS
004	TABLET;ORAL	0.5MG	1	RAPAMUNE	SIROLIMUS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-08-22	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2003-04-11	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-05-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2003-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-06-05	STANDARD
LABELING; Labeling	SUPPL	9	AP	2003-01-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2003-01-23	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-01-31	STANDARD
LABELING; Labeling	SUPPL	13	AP	2003-03-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2003-03-19	STANDARD
LABELING; Labeling	SUPPL	15	AP	2003-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2004-02-23	STANDARD
LABELING; Labeling	SUPPL	20	AP	2004-07-20	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2005-03-11	PRIORITY
LABELING; Labeling	SUPPL	27	AP	2005-06-30	STANDARD
LABELING; Labeling	SUPPL	28	AP	2005-06-30	STANDARD
LABELING; Labeling	SUPPL	30	AP	2005-10-07	STANDARD
LABELING; Labeling	SUPPL	31	AP	2005-10-07	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2006-06-02	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2006-03-10	N/A
LABELING; Labeling	SUPPL	34	AP	2006-06-02	STANDARD
LABELING; Labeling	SUPPL	35	AP	2007-01-09	STANDARD
LABELING; Labeling	SUPPL	36	AP	2006-10-19	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2007-01-30	UNKNOWN
LABELING; Labeling	SUPPL	38	AP	2007-01-12	STANDARD
LABELING; Labeling	SUPPL	39	AP	2007-05-02	STANDARD
EFFICACY; Efficacy	SUPPL	43	AP	2008-01-14	STANDARD
LABELING; Labeling	SUPPL	45	AP	2007-10-17	STANDARD
LABELING; Labeling	SUPPL	47	AP	2008-03-05	STANDARD
LABELING; Labeling	SUPPL	48	AP	2008-03-05	STANDARD
LABELING; Labeling	SUPPL	49	AP	2009-01-29	STANDARD
LABELING; Labeling	SUPPL	50	AP	2009-09-24	STANDARD
LABELING; Labeling	SUPPL	51	AP	2009-10-08	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2010-01-25	STANDARD
LABELING; Labeling	SUPPL	53	AP	2010-04-22	UNKNOWN
LABELING; Labeling	SUPPL	54	AP	2010-04-22	UNKNOWN
LABELING; Labeling	SUPPL	55	AP	2010-11-23	UNKNOWN
LABELING; Labeling	SUPPL	56	AP	2010-07-02	UNKNOWN
LABELING; Labeling	SUPPL	57	AP	2010-11-23	901 REQUIRED
LABELING; Labeling	SUPPL	58	AP	2010-11-08	UNKNOWN
LABELING; Labeling	SUPPL	59	AP	2011-07-11	UNKNOWN
REMS; REMS	SUPPL	60	AP	2011-06-06	N/A
LABELING; Labeling	SUPPL	65	AP	2012-12-10	STANDARD
LABELING; Labeling	SUPPL	67	AP	2013-03-07	STANDARD
LABELING; Labeling	SUPPL	68	AP	2013-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	2013-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2014-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2014-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	2015-03-30	STANDARD
EFFICACY; Efficacy	SUPPL	73	AP	2015-05-28	PRIORITY
LABELING; Labeling	SUPPL	74	AP	2015-03-06	STANDARD
LABELING; Labeling	SUPPL	75	AP	2015-11-05	STANDARD
LABELING; Labeling	SUPPL	76	AP	2017-04-11	STANDARD
LABELING; Labeling	SUPPL	80	AP	2018-05-23	STANDARD
LABELING; Labeling	SUPPL	81	AP	2018-01-12	STANDARD
LABELING; Labeling	SUPPL	83	AP	2019-07-15	STANDARD
LABELING; Labeling	SUPPL	84	AP	2019-04-05	STANDARD
LABELING; Labeling	SUPPL	85	AP	2020-01-02	STANDARD
LABELING; Labeling	SUPPL	86	TA	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	87	AP	2022-08-22	STANDARD
LABELING; Labeling	SUPPL	88	AP	2022-08-22	STANDARD

Submissions Property Types

ORIG	1	Null	30
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	9
SUPPL	24	Null	8
SUPPL	50	Null	6
SUPPL	51	Null	6
SUPPL	52	Null	0
SUPPL	53	Null	6
SUPPL	54	Null	6
SUPPL	55	Null	6
SUPPL	56	Null	6
SUPPL	57	Null	6
SUPPL	58	Null	6
SUPPL	59	Null	6
SUPPL	60	Null	6
SUPPL	65	Null	15
SUPPL	67	Null	15
SUPPL	68	Null	15
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	15
SUPPL	74	Null	6
SUPPL	75	Null	6
SUPPL	76	Null	7
SUPPL	80	Null	15
SUPPL	81	Null	6
SUPPL	83	Null	6
SUPPL	84	Null	6
SUPPL	85	Null	6
SUPPL	86	Orphan	5
SUPPL	87	Null	7
SUPPL	88	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB

CDER Filings

PF PRISM CV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21110
            [companyName] => PF PRISM CV
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/021083s069s070,021110s087s088lbl.pdf#page=43"]
            [products] => [{"drugName":"RAPAMUNE","activeIngredients":"SIROLIMUS","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RAPAMUNE","activeIngredients":"SIROLIMUS","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"RAPAMUNE","activeIngredients":"SIROLIMUS","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RAPAMUNE","activeIngredients":"SIROLIMUS","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/22\/2022","submission":"SUPPL-88","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/021083s069s070,021110s087s088lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2022","submission":"SUPPL-87","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/021083s069s070,021110s087s088lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2021","submission":"SUPPL-86","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021110s086lbl.pdf\"}]","notes":""},{"actionDate":"01\/02\/2020","submission":"SUPPL-85","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021083s067,021110s085lbl.pdf\"}]","notes":""},{"actionDate":"01\/02\/2020","submission":"SUPPL-85","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021083s067,021110s085lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2019","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021083s064,021110s083lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2019","submission":"SUPPL-84","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021083s065,021110s084lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2018","submission":"SUPPL-80","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021083s061,021110s080lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2018","submission":"SUPPL-81","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021083s062,021110s081lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2018","submission":"SUPPL-81","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021083s062,021110s081lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2017","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021083s059,021110s076lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2015","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021083s058,021110s075lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2015","submission":"SUPPL-73","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021083s055,021110s073lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2015","submission":"SUPPL-74","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021083s056,021110s074lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2013","submission":"SUPPL-68","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021110s068lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2013","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021083s053,021110s067lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2012","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021083s051,021110s065lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-57","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021110s057lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021110s057lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021110s055lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2010","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021110s058lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2010","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021083s046,021110s056lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2010","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021083s042s043,021110s053s054lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2010","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021083s042s043,021110s053s054lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2010","submission":"SUPPL-52","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021083s045,021110s052lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/08\/2009","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021083s041,021110s051lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2009","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021083s040,021110s050lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2009","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021083s038,021110s049lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2008","submission":"SUPPL-43","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021083s033,021110s043lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2007","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021083s034,021110s045lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2007","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021083s031,021110s039lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2007","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021083s030,021110s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2007","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021083s026,021110s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2006","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021083s028,021110s036lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2006","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021083s024s025,021110s032s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2006","submission":"SUPPL-32","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021083s024s025,021110s032s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2005","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021083s022,023,021110s030,031lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2005","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021083s022,023,021110s030,031lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2005","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021083s020,021,021110s027,028lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2005","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021083s020,021,021110s027,028lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2005","submission":"SUPPL-24","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21083s019,21110s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2004","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21083s017,21110s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2004","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21110scf018_rapamune_lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2003","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"RAPAMUNE","submission":"SIROLIMUS","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RAPAMUNE","submission":"SIROLIMUS","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RAPAMUNE","submission":"SIROLIMUS","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RAPAMUNE","submission":"SIROLIMUS","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-08-22
        )

)

NDA 021110

PF PRISM CV

FDA Drug Application

Application #021110

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

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PF PRISM CV