NDA 005856

ABBVIE

FDA Drug Application

Application #005856

Documents

• Letter: 2009-04-29
• Letter: 2012-06-08
• Medication Guide: 2012-06-15
• Label: 2012-06-11

Application Sponsors

NDA 005856

ABBVIE

Marketing Status

• Discontinued: 002
• Discontinued: 005
• Discontinued: 009

Application Products

002	SOLUTION;ORAL	200MG/5ML	0	TRIDIONE	TRIMETHADIONE
005	CAPSULE;ORAL	300MG	0	TRIDIONE	TRIMETHADIONE
009	TABLET;ORAL	150MG	1	TRIDIONE	TRIMETHADIONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1946-01-25	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1975-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1978-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1979-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1983-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-07-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-09-26
LABELING; Labeling	SUPPL	20	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	21	AP	2012-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2016-06-07

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	15
SUPPL	23	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 5856
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM308402.pdf"]
            [products] => [{"drugName":"TRIDIONE","activeIngredients":"TRIMETHADIONE","strength":"200MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIDIONE","activeIngredients":"TRIMETHADIONE","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIDIONE","activeIngredients":"TRIMETHADIONE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/06\/2012","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/005856s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2012","submission":"SUPPL-21","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/005856s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIDIONE","submission":"TRIMETHADIONE","actionType":"200MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIDIONE","submission":"TRIMETHADIONE","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIDIONE","submission":"TRIMETHADIONE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-06-06
        )

)