NDA 020182

LEADIANT BIOSCI INC

FDA Drug Application

Application #020182

Documents

• Letter: 1999-12-15
• Label: 1999-12-15
• Label: 2002-04-15
• Review: 1999-12-15
• Letter: 2002-04-15
• Letter: 2015-06-02
• Label: 2015-06-04
• Label: 2018-04-19
• Letter: 2018-04-20

Application Sponsors

NDA 020182

LEADIANT BIOSCI INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

1

CARNITOR

LEVOCARNITINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-12-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-08-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-01-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-12-01	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1998-12-15	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	1999-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-16	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2002-04-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-05-29	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-04-17	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	7	Null	14
SUPPL	13	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20182
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARNITOR","activeIngredients":"LEVOCARNITINE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/17\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020182s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018948s026,019257s012,020182s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18948S22lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/1999","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20182s6_Carnitor_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CARNITOR","submission":"LEVOCARNITINE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-17
        )

)