Application Sponsors
| ANDA 209315 | INGENUS PHARMS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 1MG/ML | 0 | ARSENIC TRIOXIDE | ARSENIC TRIOXIDE |
| 002 | INJECTABLE;INJECTION | 2MG/ML | 0 | ARSENIC TRIOXIDE | ARSENIC TRIOXIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-05-15 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-11-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
INGENUS PHARMS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 209315
[companyName] => INGENUS PHARMS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"ARSENIC TRIOXIDE","activeIngredients":"ARSENIC TRIOXIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-15
)
)