Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 5MG/VIAL | 0 | MITOMYCIN | MITOMYCIN |
002 | INJECTABLE;INJECTION | 20MG/VIAL | 0 | MITOMYCIN | MITOMYCIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-09-08 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
HONG KONG
cder:Array
(
[0] => Array
(
[ApplNo] => 214505
[companyName] => HONG KONG
[docInserts] => ["",""]
[products] => [{"drugName":"MITOMYCIN","activeIngredients":"MITOMYCIN","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MITOMYCIN","activeIngredients":"MITOMYCIN","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-09-08
)
)