Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | 1 | ELLENCE | EPIRUBICIN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | 1 | ELLENCE | EPIRUBICIN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-09-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-07-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2003-04-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2003-04-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2005-03-02 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2011-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-09-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2013-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2014-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2019-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | TA | 2020-08-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
PFIZER INC
cder:Array
(
[0] => Array
(
[ApplNo] => 50778
[companyName] => PFIZER INC
[docInserts] => ["",""]
[products] => [{"drugName":"ELLENCE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ELLENCE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/26\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050778s024s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050778s024s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050778s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050778s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2013","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050778s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050778s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050778s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050778s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2005","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/50778s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/50778lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ELLENCE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ELLENCE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"50MG\/25ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-07-26
)
)