Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE, LIPOSOMAL;INJECTION | 20MG/10ML (2MG/ML) | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
002 | INJECTABLE, LIPOSOMAL;INJECTION | 50MG/25ML (2MG/ML) | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-09-10 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ZYDUS
cder:Array
(
[0] => Array
(
[ApplNo] => 212299
[companyName] => ZYDUS
[docInserts] => ["",""]
[products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"20MG\/10ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-10
)
)