CADILA FDA Approval ANDA 208358

ANDA 208358

CADILA

FDA Drug Application

Application #208358

Application Sponsors

ANDA 208358CADILA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL25MG;37.5MG0TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208358
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;37.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-11
        )

)

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