ANDA 077802

GLENMARK PHARMS LTD

FDA Drug Application

Application #077802

Documents

• Letter: 2007-10-10
• Healthcare Professional Sheet: 2007-10-23
• Label: 2007-10-10

Application Sponsors

ANDA 077802

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	150MG	0	OXCARBAZEPINE	OXCARBAZEPINE
002	TABLET;ORAL	300MG	0	OXCARBAZEPINE	OXCARBAZEPINE
003	TABLET;ORAL	600MG	0	OXCARBAZEPINE	OXCARBAZEPINE

FDA Submissions

	ORIG	1	AP	2007-10-09
LABELING; Labeling	SUPPL	2	AP	2010-06-29
LABELING; Labeling	SUPPL	4	AP	2011-12-28
REMS; REMS	SUPPL	5	AP	2012-01-19
LABELING; Labeling	SUPPL	8	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-08-25	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-08-25	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-08-25	STANDARD

Submissions Property Types

SUPPL	2	Null	8
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77802
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/09\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/077802s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-10-09
        )

)