Documents
Application Sponsors
| NDA 050443 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BLENOXANE | BLEOMYCIN SULFATE |
| 002 | INJECTABLE;INJECTION | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BLENOXANE | BLEOMYCIN SULFATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1973-07-31 | UNKNOWN |
| LABELING; Labeling | SUPPL | 2 | AP | 1974-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1975-03-05 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1975-10-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1976-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1975-10-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1976-03-31 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1976-03-15 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1976-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1982-12-13 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1983-04-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1983-09-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1983-10-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1983-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1994-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1994-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1991-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1994-01-21 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1993-02-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1995-09-07 | |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 1996-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-09-30 | |
| LABELING; Labeling | SUPPL | 27 | AP | 2004-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 1999-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 1999-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2000-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-04-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2000-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2002-03-20 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2003-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2010-05-10 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 36 | Null | 6 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 50443
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"BLENOXANE","activeIngredients":"BLEOMYCIN SULFATE","strength":"EQ 15 UNITS BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BLENOXANE","activeIngredients":"BLEOMYCIN SULFATE","strength":"EQ 30 UNITS BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/10\/2010","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050443s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2003","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50443slr035_blenoxane_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BLENOXANE","submission":"BLEOMYCIN SULFATE","actionType":"EQ 15 UNITS BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BLENOXANE","submission":"BLEOMYCIN SULFATE","actionType":"EQ 30 UNITS BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2010-05-10
)
)