ANDA 072987

WATSON LABS TEVA

FDA Drug Application

Application #072987

Application Sponsors

ANDA 072987

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

EQ 50MG BASE

0

DOXEPIN HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1991-03-29
LABELING; Labeling	SUPPL	2	AP	1993-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-12-31
LABELING; Labeling	SUPPL	8	AP	1996-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-04-12
LABELING; Labeling	SUPPL	16	AP	2001-01-19
LABELING; Labeling	SUPPL	17	AP	2014-07-17	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	7

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72987
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXEPIN HYDROCHLORIDE","submission":"DOXEPIN HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)