ANDA 085799

LANNETT CO INC

FDA Drug Application

Application #085799

Application Sponsors

ANDA 085799

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1977-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-12-10
LABELING; Labeling	SUPPL	17	AP	1989-05-10
BIOEQUIV; Bioequivalence	SUPPL	19	AP	1992-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-06-30
LABELING; Labeling	SUPPL	22	AP	1996-07-02
LABELING; Labeling	SUPPL	23	AP	1998-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-11-24
LABELING; Labeling	SUPPL	30	AP	1999-11-08
LABELING; Labeling	SUPPL	31	AP	2002-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-12-09
LABELING; Labeling	SUPPL	35	AP	2004-07-19
LABELING; Labeling	SUPPL	36	AP	2005-12-28
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	41	AP	2016-01-21
LABELING; Labeling	SUPPL	42	AP	2016-01-21
LABELING; Labeling	SUPPL	43	AP	2016-01-21
LABELING; Labeling	SUPPL	44	AP	2016-01-21
LABELING; Labeling	SUPPL	45	AP	2016-01-21	STANDARD

Submissions Property Types

SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	32	Null	0
SUPPL	37	Null	15
SUPPL	38	Null	7
SUPPL	39	Null	7
SUPPL	41	Null	7
SUPPL	42	Null	7
SUPPL	43	Null	15
SUPPL	44	Null	15
SUPPL	45	Null	7

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85799
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)