ANDA 209779

RUBICON

FDA Drug Application

Application #209779

Application Sponsors

ANDA 209779

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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

2021-05-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209779
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.3MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.4MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROGLYCERIN","activeIngredients":"NITROGLYCERIN","strength":"0.6MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-03
        )

)