ANDA 200878

APOTEX CORP

FDA Drug Application

Application #200878

Application Sponsors

ANDA 200878

APOTEX CORP

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	120MG	0	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	180MG	0	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	240MG	0	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2012-04-20

Submissions Property Types

ORIG

1

Null

7

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200878
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/26\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-10-26
        )

)