ANDA 204158

PAR PHARM

FDA Drug Application

Application #204158

Application Sponsors

ANDA 204158

PAR PHARM

Marketing Status

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

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET, ORALLY DISINTEGRATING;ORAL	50MG	0	LAMOTRIGINE	LAMOTRIGINE
003	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	0	LAMOTRIGINE	LAMOTRIGINE
004	TABLET, ORALLY DISINTEGRATING;ORAL	200MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-27
LABELING; Labeling	SUPPL	2	AP	2020-02-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-02-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

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

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204158
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-12
        )

)