ANCHEN PHARMS FDA Approval ANDA 206665

ANDA 206665

ANCHEN PHARMS

FDA Drug Application

Application #206665

Documents

Letter2019-04-24

Application Sponsors

ANDA 206665ANCHEN PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 150MG BASE0ALISKIREN HEMIFUMARATEALISKIREN HEMIFUMARATE
002TABLET;ORALEQ 300MG BASE0ALISKIREN HEMIFUMARATEALISKIREN HEMIFUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2019-03-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ANCHEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206665
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALISKIREN HEMIFUMARATE","activeIngredients":"ALISKIREN HEMIFUMARATE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALISKIREN HEMIFUMARATE","activeIngredients":"ALISKIREN HEMIFUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206665Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-22
        )

)

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