Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION; ORAL | 2.5MG/ML | 0 | FINTEPLA | FENFLUAMINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2020-06-25 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2022-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2023-01-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 6 |
CDER Filings
ZOGENIX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212102
[companyName] => ZOGENIX INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/212102s000lbl.pdf#page=23"]
[products] => [{"drugName":"FINTEPLA","activeIngredients":"FENFLURAMINE HYDROCHLORIDE","strength":"EQ 2.2MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212102s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212102s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212102Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-06-25
)
)