Documents
Application Sponsors
| NDA 050467 | PHARMACIA AND UPJOHN | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 50MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
| 003 | INJECTABLE;INJECTION | 20MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
| 004 | INJECTABLE;INJECTION | 150MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1974-08-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1994-11-29 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1975-05-05 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1975-05-12 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1975-08-25 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1975-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1975-11-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1976-03-25 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1976-09-14 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1976-12-21 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1977-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1977-03-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1977-03-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1977-03-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1977-07-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1977-07-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1977-07-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1977-08-10 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1977-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1978-01-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1978-09-13 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1978-07-03 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1978-11-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1978-12-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 1979-03-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1979-10-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1979-10-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 1979-10-31 | |
| LABELING; Labeling | SUPPL | 30 | AP | 1980-03-31 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1981-07-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1982-03-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1982-03-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 35 | AP | 1983-02-24 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1983-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1983-08-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1985-01-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1985-03-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 41 | AP | 1985-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1985-06-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 44 | AP | 1986-02-11 | |
| LABELING; Labeling | SUPPL | 45 | AP | 1986-03-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1986-05-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1986-11-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1987-03-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1987-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 50 | AP | 1987-03-27 | |
| LABELING; Labeling | SUPPL | 52 | AP | 1987-02-19 | |
| LABELING; Labeling | SUPPL | 53 | AP | 1987-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1987-07-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 55 | AP | 1987-07-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1987-12-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1988-03-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1995-04-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1996-05-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1997-10-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 62 | AP | 1998-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 1999-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2002-09-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2002-01-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2002-04-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 67 | AP | 2002-09-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 68 | AP | 2003-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2003-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2010-07-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 71 | AP | 2011-09-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 73 | AP | 2013-10-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 2013-10-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 2015-09-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 76 | AP | 2019-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 77 | AP | 2019-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 78 | TA | 2020-03-17 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 70 | Null | 6 |
| SUPPL | 71 | Null | 6 |
| SUPPL | 73 | Null | 15 |
| SUPPL | 74 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 15 |
| SUPPL | 77 | Null | 6 |
| SUPPL | 78 | Null | 4 |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 50467
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"150MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/28\/2020","submission":"SUPPL-78","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050467s078,050629s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2019","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050467s076lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2019","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050467s077lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-73","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050467s073lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050467s073lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2011","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050467s071lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2010","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050467s070lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2003","submission":"SUPPL-69","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2003","submission":"SUPPL-68","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/050467s068lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-67","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50467s64s67,50629s10s13lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-64","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50467s64s67,50629s10s13lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"150MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2020-08-28
)
)