RUBICON FDA Approval ANDA 216211

ANDA 216211

RUBICON

FDA Drug Application

Application #216211

Application Sponsors

ANDA 216211RUBICON

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL25MG;37.5MG0TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE
002TABLET;ORAL50MG;75MG0TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216211
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"50MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-23
        )

)

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