ANDA 090170

UNICHEM LABS LTD

FDA Drug Application

Application #090170

Documents

• Label: 2011-12-16
• Review: 2011-12-16

Application Sponsors

ANDA 090170

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 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	2011-10-06
LABELING; Labeling	SUPPL	2	AP	2012-05-21
LABELING; Labeling	SUPPL	6	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-12-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-01-17	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-01-17	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-01-17	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-01-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	15	Null	7
SUPPL	21	Null	15
SUPPL	23	Null	15
SUPPL	25	Null	15

TE Codes

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

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90170
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","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"}]
            [labels] => [{"actionDate":"10\/06\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/090170Orig1s000LBL.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","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"}]
            [supplements] => 
            [actionDate] => 2011-10-06
        )

)