ANDA 085032

ANI PHARMS INC

FDA Drug Application

Application #085032

Application Sponsors

ANDA 085032

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

AMITRIPTYLINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	263	AP	1983-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	270	AP	1983-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	271	AP	1983-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	273	AP	1984-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	274	AP	1984-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	275	AP	1985-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	276	AP	1984-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	278	AP	1985-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	279	AP	1985-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	280	AP	1987-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	281	AP	1986-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	282	AP	1986-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	283	AP	1986-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	284	AP	1986-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	285	AP	1987-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	287	AP	1987-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	288	AP	1987-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	290	AP	1988-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	292	AP	1989-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	293	AP	1989-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	294	AP	1992-06-10
LABELING; Labeling	SUPPL	295	AP	1991-12-31
LABELING; Labeling	SUPPL	298	AP	1992-06-12
LABELING; Labeling	SUPPL	299	AP	1993-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	300	AP	1994-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	301	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	302	AP	1994-09-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	303	AP	1994-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	304	AP	1995-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	305	AP	1995-02-15
LABELING; Labeling	SUPPL	306	AP	1995-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	307	AP	1997-06-18
LABELING; Labeling	SUPPL	308	AP	2014-11-17	STANDARD
LABELING; Labeling	SUPPL	309	AP	2016-04-25	STANDARD

Submissions Property Types

SUPPL	263	Null	0
SUPPL	270	Null	0
SUPPL	271	Null	0
SUPPL	273	Null	0
SUPPL	274	Null	0
SUPPL	275	Null	0
SUPPL	276	Null	0
SUPPL	278	Null	0
SUPPL	279	Null	0
SUPPL	280	Null	0
SUPPL	281	Null	0
SUPPL	282	Null	0
SUPPL	283	Null	0
SUPPL	284	Null	0
SUPPL	285	Null	0
SUPPL	287	Null	0
SUPPL	288	Null	0
SUPPL	290	Null	0
SUPPL	291	Null	0
SUPPL	292	Null	0
SUPPL	293	Null	0
SUPPL	294	Null	0
SUPPL	300	Null	0
SUPPL	301	Null	0
SUPPL	302	Null	0
SUPPL	303	Null	0
SUPPL	304	Null	0
SUPPL	305	Null	0
SUPPL	307	Null	0
SUPPL	308	Null	15
SUPPL	309	Null	7

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85032
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)