SPECGX LLC FDA Approval NDA 017116

NDA 017116

SPECGX LLC

FDA Drug Application

Application #017116

Documents

Letter2005-05-27
Label2005-05-27
Letter2002-03-27
Letter2005-05-27
Letter2005-08-08
Letter2005-08-08
Letter2008-02-07
Other Important Information from FDA2006-11-27
Label2005-05-27
Label2008-02-14
Letter2017-01-03
Label2016-12-21
Label2018-02-01
Letter2018-02-02
Label2019-10-08
Letter2019-10-08
Letter2021-06-03
Label2021-06-03
Label2021-09-13
Letter2021-09-21
Label2021-12-09

Application Sponsors

NDA 017116SPECGX LLC

Marketing Status

Prescription002

Application Products

002CONCENTRATE;ORAL10MG/ML1METHADOSEMETHADONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1973-03-14STANDARD
LABELING; LabelingSUPPL2AP1977-02-11
LABELING; LabelingSUPPL7AP1980-02-06
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1980-02-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1981-11-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1982-09-07STANDARD
LABELING; LabelingSUPPL12AP1993-04-20
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-03-27STANDARD
LABELING; LabelingSUPPL15AP2005-05-26STANDARD
LABELING; LabelingSUPPL16AP2005-05-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2005-08-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2005-08-03STANDARD
LABELING; LabelingSUPPL21AP2008-02-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2014-06-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2014-09-22STANDARD
LABELING; LabelingSUPPL29AP2016-12-16STANDARD
LABELING; LabelingSUPPL32AP2018-02-01STANDARD
LABELING; LabelingSUPPL38AP2019-10-07STANDARD
LABELING; LabelingSUPPL41AP2021-06-02STANDARD
LABELING; LabelingSUPPL43AP2021-09-13STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null0
SUPPL14Null0
SUPPL18Null0
SUPPL19Null0
SUPPL26Null0
SUPPL27Null0
SUPPL29Null15
SUPPL32Null6
SUPPL38Null6
SUPPL41Null7
SUPPL43Null7

TE Codes

002PrescriptionAA

CDER Filings

SPECGX LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17116
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADOSE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/017116s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/017116s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017116s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017116s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017116s029lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017116s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017116s015,016lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017116s015,016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHADOSE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)

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