Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | 500MG/VIAL | 0 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE |
002 | INJECTABLE;INJECTION | 1GM/VIAL | 0 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE |
003 | INJECTABLE;INJECTION | 2GM/VIAL | 0 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-05-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
AMNEAL
cder:Array
(
[0] => Array
(
[ApplNo] => 210046
[companyName] => AMNEAL
[docInserts] => ["",""]
[products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-05-25
)
)