EXELA PHARMA FDA Approval NDA 215252

NDA 215252

EXELA PHARMA

FDA Drug Application

Application #215252

Documents

Letter2021-10-29
Label2021-10-29

Application Sponsors

NDA 215252EXELA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS125MG/125ML (1MG/ML)0DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE
002SOLUTION;INTRAVENOUS250MG/250ML (1MG/1ML)0DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-10-28STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

EXELA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215252
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"125MG\/125ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"250MG\/250ML (1MG\/1ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215252s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215252s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215252Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-28
        )

)

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