SAOL THERAPS RES LTD FDA Approval NDA 020075

NDA 020075

SAOL THERAPS RES LTD

FDA Drug Application

Application #020075

Documents

Letter2002-03-06
Letter2002-11-20
Letter2003-05-30
Letter2011-11-16
Letter2014-11-21
Label2011-11-16
Letter2002-03-06
Letter2003-01-17
Letter2011-03-29
Letter2013-11-20
Label2011-03-29
Label2013-03-08
Label2013-11-22
Letter2016-10-04
Label2016-10-06
Label2019-01-17
Letter2019-01-22
Letter2022-03-28
Label2022-04-05

Application Sponsors

NDA 020075SAOL THERAPS RES LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INTRATHECAL0.5MG/ML1LIORESALBACLOFEN
002INJECTABLE;INTRATHECAL2MG/ML1LIORESALBACLOFEN
003INJECTABLE;INTRATHECAL0.05MG/ML1LIORESALBACLOFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1992-06-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1994-05-20PRIORITY
EFFICACY; EfficacySUPPL4AP1996-06-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1996-11-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-03-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1998-06-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1998-08-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-08-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-05-05PRIORITY
LABELING; LabelingSUPPL14AP2002-03-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2001-05-03PRIORITY
LABELING; LabelingSUPPL16AP2002-03-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2002-11-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-12-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2003-01-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2003-05-08PRIORITY
LABELING; LabelingSUPPL21AP2011-03-25STANDARD
LABELING; LabelingSUPPL24AP2011-11-13UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2013-01-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2013-03-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2013-09-05PRIORITY
LABELING; LabelingSUPPL28AP2013-11-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2016-06-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2014-06-05PRIORITY
LABELING; LabelingSUPPL31AP2014-11-19STANDARD
LABELING; LabelingSUPPL32AP2016-09-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2016-12-22STANDARD
LABELING; LabelingSUPPL37AP2019-01-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2021-12-13N/A

Submissions Property Types

ORIG1Orphan5
SUPPL2Null14
SUPPL5Null14
SUPPL6Null14
SUPPL7Null14
SUPPL8Null14
SUPPL9Null14
SUPPL12Null14
SUPPL15Null14
SUPPL17Null14
SUPPL18Null14
SUPPL19Null14
SUPPL20Null14
SUPPL21Null7
SUPPL24Null6
SUPPL25Null14
SUPPL26Null14
SUPPL27Null14
SUPPL28Null6
SUPPL29Null14
SUPPL30Null14
SUPPL31Null7
SUPPL32Null7
SUPPL37Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

SAOL THERAPS RES LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20075
            [companyName] => SAOL THERAPS RES LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIORESAL","activeIngredients":"BACLOFEN","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LIORESAL","activeIngredients":"BACLOFEN","strength":"2MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LIORESAL","activeIngredients":"BACLOFEN","strength":"0.05MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/16\/2019","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020075s037lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020075s032lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2013","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020075s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2013","submission":"SUPPL-26","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020075s026lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/13\/2011","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020075s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020075s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LIORESAL","submission":"BACLOFEN","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LIORESAL","submission":"BACLOFEN","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LIORESAL","submission":"BACLOFEN","actionType":"0.05MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-16
        )

)
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