ANDA 077633

ZYDUS PHARMS USA

FDA Drug Application

Application #077633

Documents

• Review: 2012-02-14

Application Sponsors

ANDA 077633

ZYDUS PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET;ORAL	50MG	0	LAMOTRIGINE	LAMOTRIGINE
003	TABLET;ORAL	100MG	0	LAMOTRIGINE	LAMOTRIGINE
004	TABLET;ORAL	150MG	0	LAMOTRIGINE	LAMOTRIGINE
005	TABLET;ORAL	200MG	0	LAMOTRIGINE	LAMOTRIGINE
006	TABLET;ORAL	250MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

	ORIG	1	AP	2009-01-27
LABELING; Labeling	SUPPL	2	AP	2010-02-23
LABELING; Labeling	SUPPL	4	AP	2011-04-25
LABELING; Labeling	SUPPL	5	AP	2011-09-29
REMS; REMS	SUPPL	6	AP	2012-02-28
LABELING; Labeling	SUPPL	7	AP	2012-02-27
LABELING; Labeling	SUPPL	8	AP	2012-02-27
LABELING; Labeling	SUPPL	9	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	28	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	29	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	30	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	31	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	32	AP	2019-10-29	STANDARD
LABELING; Labeling	SUPPL	35	AP	2022-06-10	STANDARD
LABELING; Labeling	SUPPL	37	AP	2022-06-10	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	12	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	24	Null	15
SUPPL	28	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	15
SUPPL	32	Null	15
SUPPL	35	Null	7
SUPPL	37	Null	7

TE Codes

001	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77633
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","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"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","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":"50MG","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"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)