ANDA 086428

LANNETT CO INC

FDA Drug Application

Application #086428

Application Sponsors

ANDA 086428

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

20MG

0

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1979-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-12-10
LABELING; Labeling	SUPPL	14	AP	1989-07-14
BIOEQUIV; Bioequivalence	SUPPL	16	AP	1992-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-06-30
LABELING; Labeling	SUPPL	18	AP	1996-07-02
LABELING; Labeling	SUPPL	19	AP	1998-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-11-24
LABELING; Labeling	SUPPL	26	AP	1999-11-08
LABELING; Labeling	SUPPL	27	AP	2002-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2002-12-09
LABELING; Labeling	SUPPL	31	AP	2004-07-19
LABELING; Labeling	SUPPL	32	AP	2005-12-28
LABELING; Labeling	SUPPL	33	AP	2016-01-21
LABELING; Labeling	SUPPL	34	AP	2016-01-21
LABELING; Labeling	SUPPL	35	AP	2016-01-21
LABELING; Labeling	SUPPL	37	AP	2016-01-21
LABELING; Labeling	SUPPL	38	AP	2016-01-21
LABELING; Labeling	SUPPL	39	AP	2016-01-21
LABELING; Labeling	SUPPL	40	AP	2016-01-21
LABELING; Labeling	SUPPL	41	AP	2016-01-21	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	7
SUPPL	35	Null	7
SUPPL	37	Null	7
SUPPL	38	Null	7
SUPPL	39	Null	15
SUPPL	40	Null	15
SUPPL	41	Null	7

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86428
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)