Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 0.5MG BASE | 0 | AGRYLIN | ANAGRELIDE HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AGRYLIN | ANAGRELIDE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1997-03-14 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1998-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-08-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-03-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-11-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-03-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-10-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2004-12-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2004-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2004-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2008-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2009-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2010-06-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-01-31 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 2011-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2013-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2014-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2014-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2015-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2018-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2018-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2020-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2021-10-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 7 | Null | 14 |
| SUPPL | 8 | Null | 26 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 6 |
TE Codes
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 20333
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"AGRYLIN","activeIngredients":"ANAGRELIDE HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AGRYLIN","activeIngredients":"ANAGRELIDE HYDROCHLORIDE","strength":"EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020333s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020333s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020333s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020333s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2014","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020333s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020333s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020333s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020333s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020333s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2010","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020333s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2009","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020333s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2008","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020333s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2004","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20333s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2004","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20333s008,009lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2004","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20333s008,009lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/1998","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20333S2lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AGRYLIN","submission":"ANAGRELIDE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AGRYLIN","submission":"ANAGRELIDE HYDROCHLORIDE","actionType":"EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-02-28
)
)