PAR PHARM INC FDA Approval ANDA 201785

ANDA 201785

PAR PHARM INC

FDA Drug Application

Application #201785

Documents

Letter2021-09-02

Application Sponsors

ANDA 201785PAR PHARM INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 0.5MG BASE0VARENICLINEVARENICLINE
002TABLET;ORALEQ 1MG BASE0VARENICLINEVARENICLINE

FDA Submissions

N/A; Not ApplicableORIG1AP2021-08-11

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PAR PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201785
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARENICLINE","activeIngredients":"VARENICLINE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARENICLINE","activeIngredients":"VARENICLINE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-11
        )

)

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