Documents
Application Sponsors
| NDA 208147 | TRIS PHARMA INC | |
Marketing Status
Application Products
| 001 | SUSPENSION, EXTENDED RELEASE;ORAL | EQ 2.5MG BASE/ML | 1 | DYANAVEL XR | AMPHETAMINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2015-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-01-04 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2017-05-12 | N/A |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2019-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-02-25 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 7 |
CDER Filings
TRIS PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208147
[companyName] => TRIS PHARMA INC
[docInserts] => ["Medication Guide",""]
[products] => [{"drugName":"DYANAVEL XR","activeIngredients":"AMPHETAMINE","strength":"EQ 2.5MG BASE\/ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/05\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208147s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208147s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208147s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/208147s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/19\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/208147s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/208147Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/208147Orig1DyanavelTOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/208147Orig1s000SumR_6pgs_rev1rev2kc_Redacted.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"02\/05\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208147s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208147Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"05\/12\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208147s003lbl.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208147s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208147Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-02-05
)
)