ANDA 210994

AMNEAL

FDA Drug Application

Application #210994

Application Sponsors

ANDA 210994

AMNEAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	5MG/2ML (2.5MG/ML)	0	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	10MG/4ML (2.5MG/ML)	0	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210994
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"5MG\/2ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"10MG\/4ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-13
        )

)