ANDA 040220

ACTAVIS LABS FL INC

FDA Drug Application

Application #040220

Application Sponsors

ANDA 040220

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	5MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
003	TABLET;ORAL	20MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-03-25
LABELING; Labeling	SUPPL	5	AP	1998-08-19
LABELING; Labeling	SUPPL	7	AP	1999-09-02
LABELING; Labeling	SUPPL	8	AP	2001-04-20
LABELING; Labeling	SUPPL	10	AP	2003-01-21
LABELING; Labeling	SUPPL	16	AP	2008-09-23
LABELING; Labeling	SUPPL	19	AP	2009-12-01
LABELING; Labeling	SUPPL	30	AP	2014-02-24	STANDARD
LABELING; Labeling	SUPPL	31	AP	2014-02-24	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	19	Null	7
SUPPL	30	Null	15
SUPPL	31	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

WATSON LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40220
            [companyName] => WATSON LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"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":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)