ANDA 201785

PAR PHARM INC

FDA Drug Application

Application #201785

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 201785

PAR PHARM INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 0.5MG BASE	0	VARENICLINE	VARENICLINE
002	TABLET;ORAL	EQ 1MG BASE	0	VARENICLINE	VARENICLINE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2021-08-11

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)