SPECGX LLC FDA Approval NDA 019906

NDA 019906

SPECGX LLC

FDA Drug Application

Application #019906

Documents

Letter2005-01-13
Letter2012-10-29
Letter2014-07-11
Label2005-01-13
Label2007-07-16
Label2012-10-26
Label2014-07-11
Label2014-07-29
Letter2004-09-07
Letter2007-07-24
Letter2014-07-29
Other Important Information from FDA2007-05-09
Label2003-06-10
Review2007-06-12
Letter2017-05-25
Label2017-05-26
Letter2018-08-27
Label2019-05-14
Medication Guide2019-05-14
Letter2019-05-14

Application Sponsors

NDA 019906SPECGX LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL25MG1ANAFRANILCLOMIPRAMINE HYDROCHLORIDE
002CAPSULE;ORAL50MG1ANAFRANILCLOMIPRAMINE HYDROCHLORIDE
003CAPSULE;ORAL75MG1ANAFRANILCLOMIPRAMINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1989-12-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-01-31PRIORITY
LABELING; LabelingSUPPL5AP1991-04-09
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-05-15PRIORITY
LABELING; LabelingSUPPL7AP1991-04-09
LABELING; LabelingSUPPL8AP1994-04-13
LABELING; LabelingSUPPL9AP2001-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1994-07-01PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1994-07-13PRIORITY
LABELING; LabelingSUPPL12AP1994-04-13
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-10-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-10-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1995-12-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1995-11-22PRIORITY
LABELING; LabelingSUPPL17AP1997-04-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1997-02-11PRIORITY
LABELING; LabelingSUPPL19AP1997-04-02STANDARD
LABELING; LabelingSUPPL20AP1998-01-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1998-05-18PRIORITY
LABELING; LabelingSUPPL22AP1999-01-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1999-03-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1999-04-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2000-07-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2000-10-31PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2001-03-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2002-06-20PRIORITY
LABELING; LabelingSUPPL30AP2004-09-03STANDARD
LABELING; LabelingSUPPL32AP2005-01-12STANDARD
LABELING; LabelingSUPPL34AP2007-07-13STANDARD
LABELING; LabelingSUPPL37AP2012-10-26STANDARD
LABELING; LabelingSUPPL38AP2014-07-10901 REQUIRED
LABELING; LabelingSUPPL39AP2014-07-28STANDARD
LABELING; LabelingSUPPL40AP2017-05-24STANDARD
LABELING; LabelingSUPPL41AP2018-08-22STANDARD
LABELING; LabelingSUPPL43AP2019-05-10901 REQUIRED

Submissions Property Types

SUPPL4Null0
SUPPL6Null0
SUPPL10Null0
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL18Null0
SUPPL21Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL27Null0
SUPPL28Null0
SUPPL37Null7
SUPPL38Null7
SUPPL39Null15
SUPPL40Null15
SUPPL41Null6
SUPPL43Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SPECGX LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19906
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/019906s043lbl.pdf#page=27"]
            [products] => [{"drugName":"ANAFRANIL","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ANAFRANIL","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANAFRANIL","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/10\/2019","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019906s043lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019906s040lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2014","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019906s039lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2014","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019906s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019906s037lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019906s34lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2005","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019906s032lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2001","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19906s9lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANAFRANIL","submission":"CLOMIPRAMINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANAFRANIL","submission":"CLOMIPRAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANAFRANIL","submission":"CLOMIPRAMINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-10
        )

)
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