NDA 018948

LEADIANT BIOSCI INC

FDA Drug Application

Application #018948

Documents

• Letter: 2002-04-15
• Letter: 2015-06-02
• Letter: 2007-04-09
• Review: 1998-05-07
• Label: 2002-04-15
• Label: 2007-03-31
• Label: 2015-06-04
• Label: 2018-04-19
• Letter: 2018-04-20
• Review: 2019-02-15

Application Sponsors

NDA 018948

LEADIANT BIOSCI INC

Marketing Status

• Prescription: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	330MG	1	CARNITOR	LEVOCARNITINE
002	SOLUTION;ORAL	1GM/10ML	0	CARNITOR	LEVOCARNITINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1985-12-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-04-27	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1988-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-03-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-12-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-12-07	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	1992-12-16
LABELING; Labeling	SUPPL	10	AP	1992-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-05-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-04-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-04-14	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1992-07-22
LABELING; Labeling	SUPPL	16	AP	1992-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-12-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-04-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-01-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-10-21	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1998-12-15	STANDARD
LABELING; Labeling	SUPPL	22	AP	2002-04-15	STANDARD
LABELING; Labeling	SUPPL	24	AP	2007-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-02-22	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2015-05-29	STANDARD
LABELING; Labeling	SUPPL	28	AP	2018-04-17	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	4	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	13	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	20	Null	14
SUPPL	25	Null	14
SUPPL	26	Null	7
SUPPL	28	Null	6

TE Codes

001

Prescription

AB

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18948
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARNITOR","activeIngredients":"LEVOCARNITINE","strength":"330MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CARNITOR","activeIngredients":"LEVOCARNITINE","strength":"1GM\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/17\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018948s028,019257s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2015","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018948s026,019257s012,020182s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2007","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018948s024,019257s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2002","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18948S22lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CARNITOR","submission":"LEVOCARNITINE","actionType":"330MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARNITOR","submission":"LEVOCARNITINE","actionType":"1GM\/10ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2018-04-17
        )

)