ASTELLAS FDA Approval NDA 204096

NDA 204096

ASTELLAS

FDA Drug Application

Application #204096

Documents

Letter2014-02-12
Letter2014-03-04
Letter2015-12-18
Label2013-07-23
Label2015-12-17
Review2014-12-18
Letter2013-07-26
Letter2015-12-18
Label2014-03-04
Label2015-12-17
Summary Review2014-11-17
Label2018-11-30
Letter2018-12-20
Letter2019-06-12
Label2019-06-12
Medication Guide2019-06-12
Letter2020-12-31
Label2020-12-31
Medication Guide2020-12-31
Label2022-11-23
Medication Guide2022-11-23
Letter2022-11-25

Application Sponsors

NDA 204096ASTELLAS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE, EXTENDED RELEASE;ORALEQ 0.5MG BASE1ASTAGRAF XLTACROLIMUS
002CAPSULE, EXTENDED RELEASE;ORALEQ 1MG BASE1ASTAGRAF XLTACROLIMUS
003CAPSULE, EXTENDED RELEASE;ORALEQ 5MG BASE1ASTAGRAF XLTACROLIMUS

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2013-07-19STANDARD
LABELING; LabelingSUPPL2AP2014-02-28STANDARD
LABELING; LabelingSUPPL3AP2015-12-16STANDARD
LABELING; LabelingSUPPL4AP2015-12-16STANDARD
EFFICACY; EfficacySUPPL5AP2018-11-29STANDARD
LABELING; LabelingSUPPL7AP2019-06-11STANDARD
LABELING; LabelingSUPPL9AP2020-12-30STANDARD
LABELING; LabelingSUPPL10AP2022-11-22STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null6
SUPPL3Null7
SUPPL4Null7
SUPPL5Null15
SUPPL7Null15
SUPPL9Null6
SUPPL10Null6

CDER Filings

ASTELLAS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204096
            [companyName] => ASTELLAS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/204096s007lbl.pdf#page=38"]
            [products] => [{"drugName":"ASTAGRAF XL","activeIngredients":"TACROLIMUS","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ASTAGRAF XL","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ASTAGRAF XL","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204096s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204096s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204096s003s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204096s003s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204096s003s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204096s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204096s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204096s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204096Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204096Orig1s000OTOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204096Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204096s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204096Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/29\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204096s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204096Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204096s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204096Orig1s003s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204096s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204096Orig1s003s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/28\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204096s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204096Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"02\/11\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204096Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-11
        )

)
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