ANDA 203693

ACTAVIS LABS FL INC

FDA Drug Application

Application #203693

Application Sponsors

ANDA 203693

ACTAVIS LABS FL INC

Marketing Status

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

Application Products

001	TABLET;SUBLINGUAL	0.3MG	0	NITROGLYCERIN	NITROGLYCERIN
002	TABLET;SUBLINGUAL	0.4MG	0	NITROGLYCERIN	NITROGLYCERIN
003	TABLET;SUBLINGUAL	0.6MG	0	NITROGLYCERIN	NITROGLYCERIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-16

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203693
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.3MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.4MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.6MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-16
        )

)