ANDA 078134

HIKMA PHARMS

FDA Drug Application

Application #078134

Documents

• Letter: 2012-02-14

Application Sponsors

ANDA 078134

HIKMA PHARMS

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	LAMOTRIGINE	LAMOTRIGINE
002	TABLET;ORAL	100MG	0	LAMOTRIGINE	LAMOTRIGINE
003	TABLET;ORAL	150MG	0	LAMOTRIGINE	LAMOTRIGINE
004	TABLET;ORAL	200MG	0	LAMOTRIGINE	LAMOTRIGINE

FDA Submissions

	ORIG	1	AP	2011-04-19
LABELING; Labeling	SUPPL	2	AP	2011-09-29
LABELING; Labeling	SUPPL	4	AP	2012-05-17
LABELING; Labeling	SUPPL	5	AP	2014-12-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-12-14	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-12-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-11-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-06-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-06-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78134
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)