ANDA 079132

JUBILANT CADISTA

FDA Drug Application

Application #079132

Documents

• Letter: 2012-02-14

Application Sponsors

ANDA 079132

JUBILANT CADISTA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET;ORAL	100MG	0	LAMOTRIGINE	LAMOTRIGINE
003	TABLET;ORAL	150MG	0	LAMOTRIGINE	LAMOTRIGINE
004	TABLET;ORAL	200MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

	ORIG	1	AP	2009-01-27
REMS; REMS	SUPPL	2	AP	2010-11-04
LABELING; Labeling	SUPPL	7	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-09-02	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-09-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-09-02	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-12-06	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-12-06	STANDARD
LABELING; Labeling	SUPPL	27	AP	2022-07-18	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-07-18	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	7
SUPPL	16	Null	15
SUPPL	20	Null	7
SUPPL	23	Null	15
SUPPL	27	Null	7
SUPPL	28	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79132
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)