Documents
Application Sponsors
| NDA 022307 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 5MG BASE | 1 | EFFIENT | PRASUGREL HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 10MG BASE | 1 | EFFIENT | PRASUGREL HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2009-07-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-12-06 | UNKNOWN |
| LABELING; Labeling | SUPPL | 3 | AP | 2011-09-27 | UNKNOWN |
| REMS; REMS | SUPPL | 6 | AP | 2012-03-23 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2012-11-30 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2013-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2015-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2016-01-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2016-07-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 2018-03-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2019-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-12-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 18 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 22307
[companyName] => ELI LILLY AND CO
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022307s016lbl.pdf#page=20"]
[products] => [{"drugName":"EFFIENT","activeIngredients":"PRASUGREL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EFFIENT","activeIngredients":"PRASUGREL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/28\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022307s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022307s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022307s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022307s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2016","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022307s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022307s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/07\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022307s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022307s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2013","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022307s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022307s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022307s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2010","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022307s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2010","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022307s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2010","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022307s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/10\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022307s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"EFFIENT","submission":"PRASUGREL HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EFFIENT","submission":"PRASUGREL HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-28
)
)