Application Sponsors
NDA 050341 | BRISTOL MYERS SQUIBB | |
Marketing Status
Application Products
003 | SUSPENSION;ORAL | 100MG/ML | 0 | FUNGIZONE | AMPHOTERICIN B |
FDA Submissions
| ORIG | 1 | AP | 1971-06-02 | |
LABELING; Labeling | SUPPL | 3 | AP | 1996-03-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-09-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-01-17 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 50341
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"FUNGIZONE","activeIngredients":"AMPHOTERICIN B","strength":"100MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FUNGIZONE","submission":"AMPHOTERICIN B","actionType":"100MG\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)