ANDA 079099

GLENMARK PHARMS LTD

FDA Drug Application

Application #079099

Documents

• Letter: 2012-02-14
• Other Important Information from FDA: 2009-03-03

Application Sponsors

ANDA 079099

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, CHEWABLE;ORAL	5MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET, CHEWABLE;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

	ORIG	1	AP	2009-02-19
LABELING; Labeling	SUPPL	4	AP	2012-03-26
LABELING; Labeling	SUPPL	5	AP	2012-05-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-12-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-02-10	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79099
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"5MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)