Documents
Application Sponsors
| NDA 211280 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 50MG | 1 | REYVOW | LASMIDITAN SUCCINATE |
| 002 | TABLET;ORAL | 100MG | 1 | REYVOW | LASMIDITAN SUCCINATE |
| 003 | TABLET;ORAL | 200MG | 1 | REYVOW | LASMIDITAN SUCCINATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2022-01-25 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-09-15 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 211280
[companyName] => ELI LILLY AND CO
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/211280s001lbl.pdf#page=14"]
[products] => [{"drugName":"REYVOW","activeIngredients":"LASMIDITAN SUCCINATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"REYVOW","activeIngredients":"LASMIDITAN SUCCINATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211280s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211280s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211280s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211280s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211280s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211280Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211280_Orig1_toc.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211280s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211280Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-07-17
)
)