NDA 018873

BOEHRINGER INGELHEIM

FDA Drug Application

Application #018873

Documents

• Letter: 2004-06-09
• Review: 2019-02-15

Application Sponsors

NDA 018873

BOEHRINGER INGELHEIM

Marketing Status

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

Application Products

002	CAPSULE;ORAL	150MG	1	MEXITIL	MEXILETINE HYDROCHLORIDE
003	CAPSULE;ORAL	200MG	1	MEXITIL	MEXILETINE HYDROCHLORIDE
004	CAPSULE;ORAL	250MG	1	MEXITIL	MEXILETINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1985-12-30	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1987-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-05-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-09-10	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1988-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-12-22	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1991-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-03-22	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1991-10-21
LABELING; Labeling	SUPPL	10	AP	1991-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-01-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-08-13	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	1991-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-09-19	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1996-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-12-09	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2004-02-25	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18873
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEXITIL","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEXITIL","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEXITIL","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEXITIL","submission":"MEXILETINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MEXITIL","submission":"MEXILETINE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MEXITIL","submission":"MEXILETINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)