ACCORD HLTHCARE FDA Approval NDA 214652

NDA 214652

ACCORD HLTHCARE

FDA Drug Application

Application #214652

Documents

Letter2020-09-30
Label2020-09-30

Application Sponsors

NDA 214652ACCORD HLTHCARE

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION; INJECTION0.4MG/ML0ATROPINE SULFATEATROPINE SULFATE
002SOLUTION; INJECTION1MG/ML0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-09-29STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214652
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"0.4MG\/ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1MG\/ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/29\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214652s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/29\/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\\\/214652s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214652Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-29
        )

)

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