Documents
Application Sponsors
| ANDA 063165 | PHARMACIA AND UPJOHN | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 2MG/ML | 0 | ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 200MG/100ML | 0 | ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1991-01-30 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1995-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1992-06-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-07-09 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1993-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-05-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1993-10-12 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1999-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-08-16 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2011-01-05 | |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-12-05 | |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 15 |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 63165
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"ADRIAMYCIN PFS","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ADRIAMYCIN PFS","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ADRIAMYCIN PFS","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ADRIAMYCIN PFS","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)