CADILA FDA Approval ANDA 215666

ANDA 215666

CADILA

FDA Drug Application

Application #215666

Application Sponsors

ANDA 215666CADILA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG;6.25MG0BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
002TABLET;ORAL5MG;6.25MG0BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
003TABLET;ORAL10MG;6.25MG0BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215666
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"2.5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"10MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"2.5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"10MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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