NDA 018513

LEADIANT BIOSCI INC

FDA Drug Application

Application #018513

Documents

• Letter: 2010-05-24

Application Sponsors

NDA 018513

LEADIANT BIOSCI INC

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

CHENIX

CHENODIOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1983-07-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-04-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-04-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-12-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-04-17	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1986-04-24
LABELING; Labeling	SUPPL	9	AP	1986-12-22
LABELING; Labeling	SUPPL	10	AP	1988-11-16
LABELING; Labeling	SUPPL	11	AP	1990-01-03
LABELING; Labeling	SUPPL	12	AP	2010-05-20	UNKNOWN

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	12	Null	7

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18513
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHENIX","activeIngredients":"CHENODIOL","strength":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHENIX","submission":"CHENODIOL","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)