NDA 050341

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #050341

Application Sponsors

NDA 050341

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 003

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
        )

)