ANDA 204724

GLENMARK PHARMS LTD

FDA Drug Application

Application #204724

Documents

• Letter: 2019-03-12

Application Sponsors

ANDA 204724

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	400MG	0	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE
002	TABLET;ORAL	800MG	0	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-08

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204724
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SEVELAMER HYDROCHLORIDE","activeIngredients":"SEVELAMER HYDROCHLORIDE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204724Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-08
        )

)