NDA 050724

LEADIANT BIOSCI INC

FDA Drug Application

Application #050724

Application Sponsors

NDA 050724

LEADIANT BIOSCI INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE, LIPID COMPLEX;INJECTION

5MG/ML

1

ABELCET

AMPHOTERICIN B

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1995-11-20	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	1996-10-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-09-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-08-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-06-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-08-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-08-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-09-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-08-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-12-23	PRIORITY

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50724
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABELCET","activeIngredients":"AMPHOTERICIN B","strength":"5MG\/ML","dosageForm":"INJECTABLE, LIPID COMPLEX;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABELCET","submission":"AMPHOTERICIN B","actionType":"5MG\/ML","submissionClassification":"INJECTABLE, LIPID COMPLEX;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)