ANDA 201791

PAR PHARM

FDA Drug Application

Application #201791

Application Sponsors

ANDA 201791

PAR PHARM

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET, EXTENDED RELEASE;ORAL	50MG	0	LAMOTRIGINE	LAMOTRIGINE
003	TABLET, EXTENDED RELEASE;ORAL	100MG	0	LAMOTRIGINE	LAMOTRIGINE
004	TABLET, EXTENDED RELEASE;ORAL	200MG	0	LAMOTRIGINE	LAMOTRIGINE
005	TABLET, EXTENDED RELEASE;ORAL	250MG	0	LAMOTRIGINE	LAMOTRIGINE
006	TABLET, EXTENDED RELEASE;ORAL	300MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-01-18
LABELING; Labeling	SUPPL	3	AP	2015-06-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-06-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-06-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-11-09	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201791
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/10\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/10\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-10
        )

)