NDA 018013

SPECGX LLC

FDA Drug Application

Application #018013

Documents

• Letter: 2007-07-24
• Letter: 2014-07-29
• Label: 2005-01-13
• Label: 2014-07-11
• Label: 2014-07-29
• Letter: 2005-01-13
• Letter: 2012-10-29
• Letter: 2014-07-11
• Review: 2009-09-14
• Medication Guide: 2009-11-20
• Other Important Information from FDA: 2007-05-09
• Label: 2007-07-16
• Label: 2012-10-26
• Label: 2019-04-10
• Medication Guide: 2019-04-10
• Letter: 2019-04-10

Application Sponsors

NDA 018013

SPECGX LLC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 10MG BASE	1	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 25MG BASE	1	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 75MG BASE	1	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 50MG BASE	1	PAMELOR	NORTRIPTYLINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1977-08-01	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1982-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-09-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	1979-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1981-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-06-02	STANDARD
LABELING; Labeling	SUPPL	12	AP	1984-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-06-27	STANDARD
LABELING; Labeling	SUPPL	16	AP	1985-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1986-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1990-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1988-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1989-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1990-03-26	STANDARD
LABELING; Labeling	SUPPL	29	AP	1991-03-13
LABELING; Labeling	SUPPL	30	AP	1993-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1991-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1992-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1992-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1993-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1993-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1993-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1993-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1993-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1993-07-23	STANDARD
LABELING; Labeling	SUPPL	41	AP	1993-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1994-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1994-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1994-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1995-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1995-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1999-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1999-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2000-04-27	STANDARD
LABELING; Labeling	SUPPL	53	AP	2001-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2001-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2004-12-06	STANDARD
LABELING; Labeling	SUPPL	56	AP	2005-01-12	STANDARD
LABELING; Labeling	SUPPL	58	AP	2007-07-13	STANDARD
LABELING; Labeling	SUPPL	61	AP	2012-10-26	STANDARD
LABELING; Labeling	SUPPL	62	AP	2014-07-10	901 REQUIRED
LABELING; Labeling	SUPPL	63	AP	2014-07-28	STANDARD
LABELING; Labeling	SUPPL	64	AP	2019-04-09	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	61	Null	7
SUPPL	62	Null	15
SUPPL	63	Null	6
SUPPL	64	Null	6

TE Codes

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

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18013
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018013s064lbl.pdf#page=15"]
            [products] => [{"drugName":"PAMELOR","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PAMELOR","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PAMELOR","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"PAMELOR","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/09\/2019","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018013s064lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2014","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018013s063lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2014","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018013s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018012s029,018013s061lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2007","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018013s58lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2005","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/18012s026,18013s056lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PAMELOR","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PAMELOR","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PAMELOR","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PAMELOR","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-04-09
        )

)