Application Sponsors
ANDA 204948 | MARKSANS PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 1MCG | 0 | PARICALCITOL | PARICALCITOL |
002 | CAPSULE;ORAL | 2MCG | 0 | PARICALCITOL | PARICALCITOL |
003 | CAPSULE;ORAL | 4MCG | 0 | PARICALCITOL | PARICALCITOL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-10-07 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
MARKSANS PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 204948
[companyName] => MARKSANS PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"2MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"4MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-10-07
)
)