SPECGX LLC FDA Approval NDA 021217

NDA 021217

SPECGX LLC

FDA Drug Application

Application #021217

Documents

Letter2010-03-03
Letter2012-07-11
Letter2013-03-19
Letter2013-04-17
Letter2015-06-04
Letter2014-08-20
Letter2015-07-02
Label2012-08-28
Label2015-06-04
Label2014-06-26
Summary Review2010-05-23
Letter2010-03-31
Letter2012-08-28
Letter2014-06-19
Letter2014-04-17
Letter2016-04-22
Label2010-03-02
Label2012-07-12
Label2013-03-18
Label2014-04-16
Review2010-05-23
Other2012-07-11
Letter2016-10-04
Letter2016-12-20
Label2016-12-21
Letter2017-05-30
Letter2018-10-01
Letter2018-10-01
Label2018-10-17
Label2018-10-17
Label2019-10-08
Medication Guide2019-10-08
Letter2019-10-08

Application Sponsors

NDA 021217SPECGX LLC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET, EXTENDED RELEASE;ORAL8MG1EXALGOHYDROMORPHONE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL12MG1EXALGOHYDROMORPHONE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL16MG1EXALGOHYDROMORPHONE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL32MG1EXALGOHYDROMORPHONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2010-03-01STANDARD
LABELING; LabelingSUPPL2AP2012-07-09STANDARD
LABELING; LabelingSUPPL4AP2012-08-24STANDARD
LABELING; LabelingSUPPL5AP2013-03-18STANDARD
REMS; REMSSUPPL6AP2013-04-15N/A
LABELING; LabelingSUPPL9AP2015-06-02STANDARD
LABELING; LabelingSUPPL12AP2014-06-17STANDARD
LABELING; LabelingSUPPL13AP2014-04-16901 REQUIRED
REMS; REMSSUPPL14AP2014-08-19N/A
REMS; REMSSUPPL15AP2015-06-26N/A
REMS; REMSSUPPL17AP2016-04-20N/A
LABELING; LabelingSUPPL19AP2016-12-16STANDARD
REMS; REMSSUPPL20AP2016-09-30N/A
REMS; REMSSUPPL21AP2017-05-26N/A
REMS; REMSSUPPL23AP2018-09-18N/A
LABELING; LabelingSUPPL24AP2018-09-18STANDARD
LABELING; LabelingSUPPL25AP2019-10-07STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null6
SUPPL4Null15
SUPPL5Null6
SUPPL6Null7
SUPPL9Null6
SUPPL12Null7
SUPPL13Null15
SUPPL14Null6
SUPPL15Null6
SUPPL17Null15
SUPPL19Null15
SUPPL20Null15
SUPPL21Null6
SUPPL23Null6
SUPPL24Null6
SUPPL25Null7

CDER Filings

SPECGX LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21217
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021217s025lbl.pdf#page=31"]
            [products] => [{"drugName":"EXALGO","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"EXALGO","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"12MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"EXALGO","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"16MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"EXALGO","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"32MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021217s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021217s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021217s023s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-23","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021217s023s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021217s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021217s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021217Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021217Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2014","submission":"SUPPL-12","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021217Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021217s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021217s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021217s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/24\/2012","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021217s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021217s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021217s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021217lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EXALGO","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"8MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"EXALGO","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"12MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"EXALGO","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"16MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"EXALGO","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"32MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)
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