Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 0.5MCG | 0 | DOXERCALCIFEROL | DOXERCALCIFEROL |
002 | CAPSULE;ORAL | 1MCG | 0 | DOXERCALCIFEROL | DOXERCALCIFEROL |
003 | CAPSULE;ORAL | 2.5MCG | 0 | DOXERCALCIFEROL | DOXERCALCIFEROL |
FDA Submissions
| ORIG | 1 | AP | 2011-09-23 | |
| ORIG | 2 | AP | 2014-01-14 | |
LABELING; Labeling | SUPPL | 7 | AP | 2020-10-13 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
ORIG | 2 | Null | 19 |
SUPPL | 7 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
HIKMA
cder:Array
(
[0] => Array
(
[ApplNo] => 91433
[companyName] => HIKMA
[docInserts] => ["",""]
[products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"2.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"0.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"1MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"2.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)