Documents
Application Sponsors
NDA 215498 | ALBIREO PHARMA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | CAPSULE;ORAL | 400MCG | 0 | BYLVAY | ODEVIXIBAT |
002 | CAPSULE;ORAL | 1200MCG | 0 | BYLVAY | ODEVIXIBAT |
003 | PELLETS;ORAL | 200MCG | 0 | BYLVAY | ODEVIXIBAT |
004 | PELLETS;ORAL | 600MCG | 0 | BYLVAY | ODEVIXIBAT |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-07-20 | PRIORITY |
LABELING; Labeling | SUPPL | 2 | AP | 2022-10-21 | STANDARD |
Submissions Property Types
CDER Filings
ALBIREO PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215498
[companyName] => ALBIREO PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"400MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"1200MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"200MCG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BYLVAY","activeIngredients":"ODEVIXIBAT","strength":"600MCG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215498s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215498s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215498Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-07-20
)
)