Documents
Application Sponsors
NDA 210735 | AUROMEDICS PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION;INTRAVENOUS | 500MG/2.5ml (200MG/ML) | 2 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE |
002 | SOLUTION;INTRAVENOUS | 1GM/5ML (200MG/ML) | 2 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-08-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | TBD |
002 | Prescription | TBD |
CDER Filings
AUROMEDICS PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 210735
[companyName] => AUROMEDICS PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"500MG\/2.5ml (200MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"1GM\/5ML (200MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210735Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-08-25
)
)