Application Sponsors
| ANDA 212993 | GLAND PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | 0 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | 0 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-10-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-10-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 6 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 212993
[companyName] => GLAND PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-14
)
)