ANDA 202887

RUBICON

FDA Drug Application

Application #202887

Application Sponsors

ANDA 202887

RUBICON

Marketing Status

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

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-06-17
LABELING; Labeling	SUPPL	2	AP	2016-02-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-02-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-02-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-02-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	17	Null	7

TE Codes

003	Prescription	AB
004	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202887
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/17\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/22\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/22\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-22
        )

)