NDA 006383

MALLINCKRODT INC

FDA Drug Application

Application #006383

Documents

• Letter: 2016-12-19
• Label: 2016-12-21
• Label: 2018-02-01
• Letter: 2018-02-02

Application Sponsors

NDA 006383

MALLINCKRODT INC

Marketing Status

• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

002	POWDER;FOR RX COMPOUNDING	50GM/BOT	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE
003	POWDER;FOR RX COMPOUNDING	100GM/BOT	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE
004	POWDER;FOR RX COMPOUNDING	500GM/BOT	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1947-12-15	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	1977-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1980-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-06-05
LABELING; Labeling	SUPPL	17	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-02-01	STANDARD

Submissions Property Types

SUPPL	5	Null	14
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	15
SUPPL	18	Null	6

CDER Filings

MALLINCKRODT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6383
            [companyName] => MALLINCKRODT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"50GM\/BOT","dosageForm":"POWDER;FOR RX COMPOUNDING","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"100GM\/BOT","dosageForm":"POWDER;FOR RX COMPOUNDING","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"500GM\/BOT","dosageForm":"POWDER;FOR RX COMPOUNDING","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/01\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/006383s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/006383s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/006383s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/006383s017lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"50GM\/BOT","submissionClassification":"POWDER;FOR RX COMPOUNDING","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"100GM\/BOT","submissionClassification":"POWDER;FOR RX COMPOUNDING","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"500GM\/BOT","submissionClassification":"POWDER;FOR RX COMPOUNDING","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2018-02-01
        )

)