AMTA FDA Approval ANDA 216304

ANDA 216304

AMTA

FDA Drug Application

Application #216304

Application Sponsors

ANDA 216304AMTA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL120MG0DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL180MG0DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL240MG0DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB2
002PrescriptionAB2
003PrescriptionAB2

CDER Filings

AMTA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216304
            [companyName] => AMTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-08
        )

)

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