ACER THERAPEUTICS INC FDA Approval NDA 214860

NDA 214860

ACER THERAPEUTICS INC

FDA Drug Application

Application #214860

Documents

Letter2022-12-23
Label2022-12-27

Application Sponsors

NDA 214860ACER THERAPEUTICS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001SUSPENSION;ORAL2G2OLPRUVASODIUM PHENYLBUTYRATE
002SUSPENSION;ORAL3G2OLPRUVASODIUM PHENYLBUTYRATE
003SUSPENSION;ORAL4G2OLPRUVASODIUM PHENYLBUTYRATE
004SUSPENSION;ORAL5G2OLPRUVASODIUM PHENYLBUTYRATE
005SUSPENSION;ORAL6G2OLPRUVASODIUM PHENYLBUTYRATE
006SUSPENSION;ORAL6.67G2OLPRUVASODIUM PHENYLBUTYRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-12-22STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

ACER THERAPEUTICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214860
            [companyName] => ACER THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLPRUVA","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"2G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"OLPRUVA","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"3G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"OLPRUVA","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"4G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"OLPRUVA","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"5G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"OLPRUVA","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"6G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"OLPRUVA","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"6.67G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214860s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/22\/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\\\/214860s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214860Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-22
        )

)

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