ANDA 088887

PLIVA

FDA Drug Application

Application #088887

Application Sponsors

ANDA 088887

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

AMITRIPTYLINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1991-07-29
BIOEQUIV; Bioequivalence	SUPPL	7	AP	1990-02-14
LABELING; Labeling	SUPPL	8	AP	1990-10-26
LABELING; Labeling	SUPPL	10	AP	1992-05-26
LABELING; Labeling	SUPPL	11	AP	1993-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-05-11
LABELING; Labeling	SUPPL	13	AP	1995-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-07-14
LABELING; Labeling	SUPPL	15	AP	1995-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-07-07
LABELING; Labeling	SUPPL	17	AP	2000-10-05
LABELING; Labeling	SUPPL	19	AP	2001-06-25

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88887
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)