ANDA 089601

LANNETT CO INC

FDA Drug Application

Application #089601

Documents

• Other Important Information from FDA: 2007-05-18

Application Sponsors

ANDA 089601

LANNETT CO INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

20MG

0

METADATE ER

METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-09-11
LABELING; Labeling	SUPPL	6	AP	1996-07-02
LABELING; Labeling	SUPPL	7	AP	1998-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-02-22
LABELING; Labeling	SUPPL	12	AP	1999-10-20
LABELING; Labeling	SUPPL	14	AP	1999-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-10-23
LABELING; Labeling	SUPPL	16	AP	2002-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-12-09
LABELING; Labeling	SUPPL	22	AP	2005-12-28
LABELING; Labeling	SUPPL	23	AP	2016-01-21
LABELING; Labeling	SUPPL	24	AP	2016-01-21
LABELING; Labeling	SUPPL	25	AP	2016-01-21
LABELING; Labeling	SUPPL	27	AP	2016-01-21
LABELING; Labeling	SUPPL	28	AP	2016-01-21
LABELING; Labeling	SUPPL	29	AP	2011-08-31
LABELING; Labeling	SUPPL	30	AP	2016-01-21
LABELING; Labeling	SUPPL	31	AP	2016-01-21	STANDARD
LABELING; Labeling	SUPPL	36	AP	2021-06-25	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	23	Null	7
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	15
SUPPL	31	Null	15
SUPPL	36	Null	15

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89601
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METADATE ER","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METADATE ER","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)