RUBICON FDA Approval ANDA 209779

ANDA 209779

RUBICON

FDA Drug Application

Application #209779

Application Sponsors

ANDA 209779RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;SUBLINGUAL0.3MG0NITROGLYCERINNITROGLYCERIN
002TABLET;SUBLINGUAL0.4MG0NITROGLYCERINNITROGLYCERIN
003TABLET;SUBLINGUAL0.6MG0NITROGLYCERINNITROGLYCERIN

FDA Submissions

UNKNOWN; ORIG1AP2021-05-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

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
        )

)

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