TEVA PHARMS USA INC FDA Approval NDA 208574

NDA 208574

TEVA PHARMS USA INC

FDA Drug Application

Application #208574

Documents

Label2020-03-16
Label2020-03-16
Letter2020-03-17
Letter2020-03-17
Review2020-10-08
Review2020-10-08
Letter2021-12-09
Label2021-12-13

Application Sponsors

NDA 208574TEVA PHARMS USA INC

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS10MG/2ML (5MG/ML)1ROMIDEPSINROMIDEPSIN
002SOLUTION;INTRAVENOUS27.5MG/5.5ML (5MG/ML)1ROMIDEPSINROMIDEPSIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-03-13STANDARD
EFFICACY; EfficacyORIG2AP2020-03-13STANDARD
LABELING; LabelingSUPPL6AP2021-12-08STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null15
SUPPL6Null6

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208574
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROMIDEPSIN","activeIngredients":"ROMIDEPSIN","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ROMIDEPSIN","activeIngredients":"ROMIDEPSIN","strength":"27.5MG\/5.5ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/13\/2020","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574Orig2lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/13\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574Orig2lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208574Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/208574Orig1s000,Orig2s000TOC.cfm\"}]","notes":">"},{"actionDate":"03\/13\/2020","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\\\/2020\\\/208574s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208574Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/208574Orig1s000,Orig2s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-13
        )

)

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