RECORDATI RARE FDA Approval NDA 005378

NDA 005378

RECORDATI RARE

FDA Drug Application

Application #005378

Documents

Letter2013-08-27
Letter2006-04-13
Letter2007-05-16
Letter2013-12-09
Letter2015-04-21
Label2007-05-16
Label2003-04-03
Label2006-04-13
Label2013-08-27
Label2013-12-04
Label2015-04-20
Other Important Information from FDA2011-12-20
Label2017-01-06
Letter2017-01-11
Label2017-05-22
Letter2017-05-24
Letter2019-04-15
Label2019-05-23
Medication Guide2019-05-23
Letter2022-02-28
Label2022-03-01
Medication Guide2022-03-01

Application Sponsors

NDA 005378RECORDATI RARE

Marketing Status

Prescription002
Discontinued003
Discontinued004
Discontinued005

Application Products

002TABLET;ORAL5MG1DESOXYNMETHAMPHETAMINE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL10MG0DESOXYNMETHAMPHETAMINE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL5MG0DESOXYNMETHAMPHETAMINE HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORAL15MG0DESOXYNMETHAMPHETAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP1943-12-31UNKNOWN
LABELING; LabelingSUPPL3AP1975-07-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1975-07-22
LABELING; LabelingSUPPL6AP1975-07-22
LABELING; LabelingSUPPL9AP1979-03-30
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1981-09-30
LABELING; LabelingSUPPL13AP1984-02-22
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1982-09-22
LABELING; LabelingSUPPL15AP1983-06-27
LABELING; LabelingSUPPL16AP1983-04-25
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1989-07-27
LABELING; LabelingSUPPL20AP2001-12-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1998-05-13
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1999-06-16
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2000-11-20
LABELING; LabelingSUPPL24AP2006-04-12STANDARD
LABELING; LabelingSUPPL26AP2007-05-11STANDARD
LABELING; LabelingSUPPL27AP2013-08-23STANDARD
LABELING; LabelingSUPPL28AP2013-12-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2015-01-26
LABELING; LabelingSUPPL30AP2015-04-17901 REQUIRED
LABELING; LabelingSUPPL31AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL34AP2017-05-19901 REQUIRED
LABELING; LabelingSUPPL35AP2019-04-11STANDARD
LABELING; LabelingSUPPL37AP2022-02-25901 REQUIRED

Submissions Property Types

SUPPL5Null0
SUPPL11Null0
SUPPL14Null0
SUPPL19Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL27Null15
SUPPL28Null15
SUPPL29Null0
SUPPL30Null6
SUPPL31Null6
SUPPL34Null7
SUPPL35Null15
SUPPL37Null15

TE Codes

002PrescriptionAA

CDER Filings

RECORDATI RARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 5378
            [companyName] => RECORDATI RARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/005378s035lbl.pdf#page=12"]
            [products] => [{"drugName":"DESOXYN","activeIngredients":"METHAMPHETAMINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DESOXYN","activeIngredients":"METHAMPHETAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DESOXYN","activeIngredients":"METHAMPHETAMINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DESOXYN","activeIngredients":"METHAMPHETAMINE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/11\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/005378s035lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/005378s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/005378s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/005378s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2013","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/005378s028lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2013","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/0005378s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2007","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/005378s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2006","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/005378s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2001","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/05378s20ltr.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DESOXYN","submission":"METHAMPHETAMINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DESOXYN","submission":"METHAMPHETAMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DESOXYN","submission":"METHAMPHETAMINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DESOXYN","submission":"METHAMPHETAMINE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-04-11
        )

)
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