Documents
Application Sponsors
Marketing Status
Application Products
001 | CAPSULE, DELAYED RELEASE; ORAL | 20MG | 0 | MYCAPSSA | OCTREOTIDE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2020-06-26 | STANDARD |
Submissions Property Types
CDER Filings
CHIASMA
cder:Array
(
[0] => Array
(
[ApplNo] => 208232
[companyName] => CHIASMA
[docInserts] => ["",""]
[products] => [{"drugName":"MYCAPSSA","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208232s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208232s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208232Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-06-26
)
)