Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 1MG BASE | 1 | PROGRAF | TACROLIMUS |
002 | CAPSULE;ORAL | EQ 5MG BASE | 1 | PROGRAF | TACROLIMUS |
003 | CAPSULE;ORAL | EQ 0.5MG BASE | 1 | PROGRAF | TACROLIMUS |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1994-04-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-06-22 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-06-22 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1995-06-22 | PRIORITY |
LABELING; Labeling | SUPPL | 6 | AP | 1996-04-25 | STANDARD |
EFFICACY; Efficacy | SUPPL | 7 | AP | 1997-04-22 | STANDARD |
EFFICACY; Efficacy | SUPPL | 8 | AP | 1997-04-22 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-04-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-08-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-08-24 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 13 | AP | 2000-12-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-05-08 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 2001-07-25 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2001-07-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-10-24 | PRIORITY |
LABELING; Labeling | SUPPL | 21 | AP | 2004-06-16 | STANDARD |
EFFICACY; Efficacy | SUPPL | 24 | AP | 2006-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2005-12-13 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2006-04-27 | STANDARD |
EFFICACY; Efficacy | SUPPL | 27 | AP | 2009-05-19 | UNKNOWN |
LABELING; Labeling | SUPPL | 34 | AP | 2009-02-13 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2011-07-14 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2011-07-14 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2012-02-06 | STANDARD |
LABELING; Labeling | SUPPL | 40 | AP | 2012-07-05 | STANDARD |
LABELING; Labeling | SUPPL | 41 | AP | 2012-08-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2013-01-28 | PRIORITY |
LABELING; Labeling | SUPPL | 43 | AP | 2013-09-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2014-03-19 | PRIORITY |
LABELING; Labeling | SUPPL | 45 | AP | 2015-05-19 | STANDARD |
LABELING; Labeling | SUPPL | 47 | AP | 2018-05-24 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2018-12-02 | STANDARD |
LABELING; Labeling | SUPPL | 50 | AP | 2019-06-11 | STANDARD |
LABELING; Labeling | SUPPL | 52 | AP | 2020-12-30 | STANDARD |
EFFICACY; Efficacy | SUPPL | 53 | AP | 2021-07-16 | PRIORITY |
LABELING; Labeling | SUPPL | 54 | AP | 2022-11-22 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 11 |
SUPPL | 3 | Null | 14 |
SUPPL | 4 | Null | 14 |
SUPPL | 5 | Null | 14 |
SUPPL | 9 | Null | 14 |
SUPPL | 10 | Null | 14 |
SUPPL | 11 | Null | 14 |
SUPPL | 14 | Null | 14 |
SUPPL | 17 | Null | 14 |
SUPPL | 36 | Null | 7 |
SUPPL | 37 | Null | 6 |
SUPPL | 38 | Null | 6 |
SUPPL | 40 | Null | 15 |
SUPPL | 41 | Null | 6 |
SUPPL | 42 | Null | 14 |
SUPPL | 43 | Null | 6 |
SUPPL | 44 | Null | 14 |
SUPPL | 45 | Null | 7 |
SUPPL | 47 | Null | 7 |
SUPPL | 48 | Null | 7 |
SUPPL | 50 | Null | 7 |
SUPPL | 52 | Null | 7 |
SUPPL | 53 | Null | 7 |
SUPPL | 54 | Null | 6 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
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
)
)