Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | EQ 0.2MG BASE/PACKET | 1 | PROGRAF | TACROLIMUS |
| 002 | FOR SUSPENSION;ORAL | EQ 1MG BASE/PACKET | 1 | PROGRAF | TACROLIMUS |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2018-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-12-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2021-07-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-11-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 210115
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"PROGRAF","activeIngredients":"TACROLIMUS","strength":"EQ 0.2MG BASE\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PROGRAF","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050708s050,050709s042,210115s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210115s000,050708s047,050709s040lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210115s000,050708s047,050709s040lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210115Orig1s000,050708Orig1s047,050709Orig1s040ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210115Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-2","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-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210115s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-06-11
)
)