ANDA 216211

RUBICON

FDA Drug Application

Application #216211

Application Sponsors

ANDA 216211

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG;37.5MG	0	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE
002	TABLET;ORAL	50MG;75MG	0	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)