Documents
Application Sponsors
NDA 212994 | COMMCAVE THERAPEUTICS SA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 26.1MG/5.2MG | 2 | AZSTARYS | SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE |
002 | CAPSULE;ORAL | 39.2MG/7.8MG | 2 | AZSTARYS | SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE |
003 | CAPSULE;ORAL | 52.3MG/10.4MG | 2 | AZSTARYS | SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE |
FDA Submissions
TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2021-03-02 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | TBD |
002 | Prescription | TBD |
003 | Prescription | TBD |
CDER Filings
COMMCAVE THERAPEUTICS SA
cder:Array
(
[0] => Array
(
[ApplNo] => 212994
[companyName] => COMMCAVE THERAPEUTICS SA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/212994s000lbl.pdf#page=26"]
[products] => [{"drugName":"AZSTARYS","activeIngredients":"SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE","strength":"26.1MG\/5.2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"AZSTARYS","activeIngredients":"SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE","strength":"39.2MG\/7.8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"AZSTARYS","activeIngredients":"SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE","strength":"52.3MG\/10.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"03\/02\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212994s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212994s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212994Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-03-02
)
)