Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
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 |
003 | INJECTABLE;INJECTION | 300MG/15ML (20MG/ML) | 0 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-05-03 | |
LABELING; Labeling | SUPPL | 3 | AP | 2020-06-03 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2020-06-03 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 15 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
QILU
cder:Array
(
[0] => Array
(
[ApplNo] => 203380
[companyName] => QILU
[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"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"300MG\/15ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203380Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/03\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-03
)
)