Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | 0 | EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | 0 | EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2007-10-22 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-12-20 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-01-27 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
CIPLA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 65361
[companyName] => CIPLA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"50MG\/25ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)