SAOL THERAPS RES LTD FDA Approval NDA 215422

NDA 215422

SAOL THERAPS RES LTD

FDA Drug Application

Application #215422

Documents

Letter2021-11-23
Label2021-11-23

Application Sponsors

NDA 215422SAOL THERAPS RES LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001GRANULE;ORAL5MG2LYVISPAHBACLOFEN
002GRANULE;ORAL10MG2LYVISPAHBACLOFEN
003GRANULE;ORAL20MG2LYVISPAHBACLOFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-11-22STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD

CDER Filings

SAOL THERAPS RES LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215422
            [companyName] => SAOL THERAPS RES LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LYVISPAH","activeIngredients":"BACLOFEN","strength":"5MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"LYVISPAH","activeIngredients":"BACLOFEN","strength":"10MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"LYVISPAH","activeIngredients":"BACLOFEN","strength":"20MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215422lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215422lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215422Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-22
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.