NDA 215422

SAOL THERAPS RES LTD

FDA Drug Application

Application #215422

Documents

• Letter: 2021-11-23
• Label: 2021-11-23
• Review: 2022-07-29

Application Sponsors

NDA 215422

SAOL THERAPS RES LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	GRANULE;ORAL	5MG	2	LYVISPAH	BACLOFEN
002	GRANULE;ORAL	10MG	2	LYVISPAH	BACLOFEN
003	GRANULE;ORAL	20MG	2	LYVISPAH	BACLOFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD

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
        )

)