INNOPHARMA FDA Approval NDA 206968

NDA 206968

INNOPHARMA

FDA Drug Application

Application #206968

Documents

Label2022-06-07
Letter2022-06-08

Application Sponsors

NDA 206968INNOPHARMA

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)1ACETAMINOPHENACETAMINOPHEN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-06-03STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

INNOPHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206968
            [companyName] => INNOPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/03\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206968s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/03\/2022","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\\\/2022\\\/206968s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/206968Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-06-03
        )

)

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