ASTELLAS FDA Approval NDA 050708

NDA 050708

ASTELLAS

FDA Drug Application

Application #050708

Documents

Letter2004-06-23
Letter2006-04-05
Letter2005-12-16
Letter2006-05-01
Letter2009-05-27
Letter2011-07-19
Letter2012-02-08
Letter2012-08-15
Label2003-05-02
Label2006-05-01
Label2009-05-21
Label2009-02-20
Label2011-07-18
Label2011-07-18
Label2012-07-10
Label2012-08-15
Label2013-09-09
Label2015-05-21
Letter2009-02-18
Letter2011-07-19
Letter2012-07-09
Letter2013-09-09
Letter2015-05-21
Label2004-06-14
Label2003-05-02
Label2003-05-02
Label2004-06-23
Label2012-02-06
Review2003-09-10
Review2012-10-11
Other2012-10-11
Label2018-05-29
Letter2018-05-29
Label2018-12-04
Letter2018-12-07
Label2019-06-12
Letter2020-12-31
Label2020-12-31
Label2021-07-16
Letter2021-07-19
Review2022-06-13
Label2022-11-23
Medication Guide2022-11-23
Letter2022-11-25

Application Sponsors

NDA 050708ASTELLAS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 1MG BASE1PROGRAFTACROLIMUS
002CAPSULE;ORALEQ 5MG BASE1PROGRAFTACROLIMUS
003CAPSULE;ORALEQ 0.5MG BASE1PROGRAFTACROLIMUS

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1994-04-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1995-06-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1995-06-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1995-06-22PRIORITY
LABELING; LabelingSUPPL6AP1996-04-25STANDARD
EFFICACY; EfficacySUPPL7AP1997-04-22STANDARD
EFFICACY; EfficacySUPPL8AP1997-04-22UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-04-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-08-24PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1998-08-24PRIORITY
EFFICACY; EfficacySUPPL13AP2000-12-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-05-08PRIORITY
LABELING; LabelingSUPPL15AP2001-07-25STANDARD
LABELING; LabelingSUPPL16AP2001-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2002-10-24PRIORITY
LABELING; LabelingSUPPL21AP2004-06-16STANDARD
EFFICACY; EfficacySUPPL24AP2006-03-29STANDARD
LABELING; LabelingSUPPL25AP2005-12-13STANDARD
LABELING; LabelingSUPPL26AP2006-04-27STANDARD
EFFICACY; EfficacySUPPL27AP2009-05-19UNKNOWN
LABELING; LabelingSUPPL34AP2009-02-13STANDARD
LABELING; LabelingSUPPL36AP2011-07-14STANDARD
LABELING; LabelingSUPPL37AP2011-07-14STANDARD
LABELING; LabelingSUPPL38AP2012-02-06STANDARD
LABELING; LabelingSUPPL40AP2012-07-05STANDARD
LABELING; LabelingSUPPL41AP2012-08-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL42AP2013-01-28PRIORITY
LABELING; LabelingSUPPL43AP2013-09-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2014-03-19PRIORITY
LABELING; LabelingSUPPL45AP2015-05-19STANDARD
LABELING; LabelingSUPPL47AP2018-05-24STANDARD
LABELING; LabelingSUPPL48AP2018-12-02STANDARD
LABELING; LabelingSUPPL50AP2019-06-11STANDARD
LABELING; LabelingSUPPL52AP2020-12-30STANDARD
EFFICACY; EfficacySUPPL53AP2021-07-16PRIORITY
LABELING; LabelingSUPPL54AP2022-11-22STANDARD

Submissions Property Types

ORIG1Null11
SUPPL3Null14
SUPPL4Null14
SUPPL5Null14
SUPPL9Null14
SUPPL10Null14
SUPPL11Null14
SUPPL14Null14
SUPPL17Null14
SUPPL36Null7
SUPPL37Null6
SUPPL38Null6
SUPPL40Null15
SUPPL41Null6
SUPPL42Null14
SUPPL43Null6
SUPPL44Null14
SUPPL45Null7
SUPPL47Null7
SUPPL48Null7
SUPPL50Null7
SUPPL52Null7
SUPPL53Null7
SUPPL54Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ASTELLAS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50708
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGRAF","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PROGRAF","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"PROGRAF","activeIngredients":"TACROLIMUS","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-50","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-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050708s048lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2018","submission":"SUPPL-47","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-45","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-43","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-41","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-40","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-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050708s038lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2011","submission":"SUPPL-37","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-36","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-27","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-34","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-26","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-21","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-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50708s15s16lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2001","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50708s15s16lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2000","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50708s13lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/1998","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50709s10lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"PROGRAF","submission":"TACROLIMUS","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROGRAF","submission":"TACROLIMUS","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROGRAF","submission":"TACROLIMUS","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-11
        )

)
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