ANDA 073556

MAYNE PHARMA

FDA Drug Application

Application #073556

Application Sponsors

ANDA 073556

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	EQ 75MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 10MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 25MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 50MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1992-03-30
LABELING; Labeling	SUPPL	4	AP	1993-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-05-25
LABELING; Labeling	SUPPL	10	AP	1995-12-05
LABELING; Labeling	SUPPL	11	AP	1997-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-04-25
LABELING; Labeling	SUPPL	16	AP	2002-01-04
LABELING; Labeling	SUPPL	22	AP	2005-07-26
LABELING; Labeling	SUPPL	24	AP	2006-11-01
LABELING; Labeling	SUPPL	29	AP	2007-04-12
LABELING; Labeling	SUPPL	32	AP	2007-07-03
LABELING; Labeling	SUPPL	34	AP	2008-02-20
LABELING; Labeling	SUPPL	50	AP	2015-07-15	STANDARD
LABELING; Labeling	SUPPL	52	AP	2015-07-15	STANDARD
LABELING; Labeling	SUPPL	55	AP	2020-02-21	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	50	Null	7
SUPPL	52	Null	7
SUPPL	55	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73556
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)