ANDA 078009

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078009

Documents

• Review: 2012-02-14

Application Sponsors

ANDA 078009

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET, CHEWABLE; ORAL	2MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET, CHEWABLE;ORAL	5MG	0	LAMOTRIGINE	LAMOTRIGINE
003	TABLET, CHEWABLE;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

	ORIG	1	AP	2009-01-22
LABELING; Labeling	SUPPL	3	AP	2010-06-23
LABELING; Labeling	SUPPL	4	AP	2010-06-23
LABELING; Labeling	SUPPL	5	AP	2011-04-25
LABELING; Labeling	SUPPL	6	AP	2011-09-29
REMS; REMS	SUPPL	7	AP	2012-03-07
LABELING; Labeling	SUPPL	8	AP	2012-03-14
LABELING; Labeling	SUPPL	9	AP	2012-03-14
LABELING; Labeling	SUPPL	10	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	15	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	27	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-06-10	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-06-10	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	3	Null	8
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	15
SUPPL	28	Null	15
SUPPL	29	Null	15

TE Codes

002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78009
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"2MG","dosageForm":"TABLET, CHEWABLE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"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":"2MG","submissionClassification":"TABLET, CHEWABLE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"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
        )

)