ANDA 077662

GLENMARK PHARMS LTD

FDA Drug Application

Application #077662

Application Sponsors

ANDA 077662

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
002	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2006-08-18
LABELING; Labeling	SUPPL	6	AP	2009-11-20
LABELING; Labeling	SUPPL	8	AP	2011-08-29
LABELING; Labeling	SUPPL	9	AP	2011-09-29
LABELING; Labeling	SUPPL	10	AP	2011-11-25
LABELING; Labeling	SUPPL	13	AP	2014-03-25	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2017-10-05	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-10-27	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-10-27	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	19	Null	15
SUPPL	21	Null	15
SUPPL	23	Null	15
SUPPL	26	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77662
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)