ANDA 207170

PAR PHARM INC

FDA Drug Application

Application #207170

Application Sponsors

ANDA 207170

PAR PHARM INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 2MG BASE	0	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 4MG BASE	0	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-01-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207170
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-26
        )

)