GLENMARK PHARMS LTD FDA Approval ANDA 079099

ANDA 079099

GLENMARK PHARMS LTD

FDA Drug Application

Application #079099

Documents

Letter2012-02-14
Other Important Information from FDA2009-03-03

Application Sponsors

ANDA 079099GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, CHEWABLE;ORAL5MG0LAMOTRIGINELAMOTRIGINE
002TABLET, CHEWABLE;ORAL25MG0LAMOTRIGINELAMOTRIGINE

FDA Submissions

ORIG1AP2009-02-19
LABELING; LabelingSUPPL4AP2012-03-26
LABELING; LabelingSUPPL5AP2012-05-31STANDARD
LABELING; LabelingSUPPL6AP2014-12-08STANDARD
LABELING; LabelingSUPPL7AP2020-02-10STANDARD
LABELING; LabelingSUPPL8AP2020-02-10STANDARD
LABELING; LabelingSUPPL9AP2020-02-10STANDARD
LABELING; LabelingSUPPL10AP2020-02-10STANDARD
LABELING; LabelingSUPPL11AP2020-02-10STANDARD
LABELING; LabelingSUPPL12AP2020-02-10STANDARD
LABELING; LabelingSUPPL13AP2020-02-10STANDARD
LABELING; LabelingSUPPL14AP2020-02-10STANDARD

Submissions Property Types

SUPPL1Null7
SUPPL4Null15
SUPPL5Null15
SUPPL6Null7
SUPPL7Null15
SUPPL8Null15
SUPPL9Null15
SUPPL10Null7
SUPPL11Null7
SUPPL12Null15
SUPPL13Null15
SUPPL14Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79099
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"5MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.