NDA 050709

ASTELLAS

FDA Drug Application

Application #050709

Documents

• Letter: 2005-12-16
• Letter: 2009-05-27
• Letter: 2009-02-18
• Letter: 2011-07-19
• Letter: 2012-02-08
• Letter: 2012-07-09
• Letter: 2012-08-15
• Letter: 2013-09-09
• Letter: 2015-05-21
• Label: 2003-05-02
• Label: 2004-06-23
• Label: 2009-05-21
• Label: 2011-07-18
• Label: 2011-07-18
• Label: 2012-08-15
• Label: 2013-09-09
• Letter: 2004-06-23
• Letter: 2006-04-05
• Letter: 2006-05-01
• Letter: 2011-07-19
• Label: 2003-05-02
• Label: 2006-05-01
• Label: 2009-02-20
• Label: 2012-02-06
• Label: 2012-07-10
• Label: 2015-05-21
• Review: 2003-09-10
• Review: 2012-10-11
• Other: 2012-10-11
• Label: 2018-05-29
• Letter: 2018-05-29
• Label: 2018-12-04
• Letter: 2018-12-07
• Label: 2019-06-12
• Letter: 2020-12-31
• Label: 2020-12-31
• Label: 2021-07-16
• Letter: 2021-07-19
• Review: 2022-06-13
• Label: 2022-11-23
• Medication Guide: 2022-11-23
• Letter: 2022-11-25

Application Sponsors

NDA 050709

ASTELLAS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

1

PROGRAF

TACROLIMUS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1994-04-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-06-22	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1996-04-25	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	1997-04-22	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	1997-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-04-20	PRIORITY
EFFICACY; Efficacy	SUPPL	10	AP	2000-12-01	STANDARD
LABELING; Labeling	SUPPL	12	AP	2001-07-25	STANDARD
LABELING; Labeling	SUPPL	13	AP	2004-06-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2005-12-13	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2006-03-29	STANDARD
LABELING; Labeling	SUPPL	20	AP	2006-04-27	STANDARD
EFFICACY; Efficacy	SUPPL	21	AP	2009-05-19	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2009-02-13	STANDARD
LABELING; Labeling	SUPPL	28	AP	2011-07-14	STANDARD
LABELING; Labeling	SUPPL	30	AP	2011-07-14	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2012-02-06	STANDARD
LABELING; Labeling	SUPPL	33	AP	2012-07-05	STANDARD
LABELING; Labeling	SUPPL	34	AP	2012-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2013-08-16	PRIORITY
LABELING; Labeling	SUPPL	36	AP	2013-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2015-07-01	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2015-05-19	STANDARD
LABELING; Labeling	SUPPL	40	AP	2018-05-24	STANDARD
LABELING; Labeling	SUPPL	41	AP	2018-12-02	STANDARD
LABELING; Labeling	SUPPL	42	AP	2019-06-11	STANDARD
LABELING; Labeling	SUPPL	44	AP	2020-12-30	STANDARD
EFFICACY; Efficacy	SUPPL	45	AP	2021-07-16	PRIORITY
LABELING; Labeling	SUPPL	47	AP	2022-11-22	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	28	Null	6
SUPPL	30	Null	7
SUPPL	31	Null	15
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	35	Null	0
SUPPL	36	Null	15
SUPPL	37	Null	0
SUPPL	38	Null	15
SUPPL	40	Null	15
SUPPL	41	Null	31
SUPPL	42	Null	6
SUPPL	44	Null	15
SUPPL	45	Null	6
SUPPL	47	Null	6

TE Codes

001

Prescription

AP

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50709
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGRAF","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050708s050,050709s042,210115s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2018","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050709s041lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210115s000,050708s047,050709s040lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2015","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050708s045,050709s038lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050708s043,050709s036lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2012","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050708s041,050709s034lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2012","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050708s040,050709s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050709s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2011","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050708s036s037,050709s028s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2011","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050708s036s037,050709s028s030lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2009","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050708s027,050709s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050708s034,050709s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2006","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050708s026,050709s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2004","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50708slr021,50709slr013_prograf_lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2001","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50709s12lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2000","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50709s10lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROGRAF","submission":"TACROLIMUS","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-11
        )

)