NDA 018012

SPECGX LLC

FDA Drug Application

Application #018012

Documents

• Letter: 2005-01-13
• Letter: 2007-07-24
• Letter: 2012-10-29
• Letter: 2014-07-11
• Label: 2005-01-13
• Label: 2012-10-26
• Label: 2014-07-11
• Letter: 2014-07-29
• Label: 2003-04-11
• Label: 2007-07-16
• Label: 2014-07-29
• Review: 2009-09-14
• Medication Guide: 2009-11-20
• Other Important Information from FDA: 2007-05-09

Application Sponsors

NDA 018012

SPECGX LLC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

EQ 10MG BASE/5ML

0

PAMELOR

NORTRIPTYLINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1977-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1981-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-07-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	1984-05-01
LABELING; Labeling	SUPPL	10	AP	1985-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-12-23	STANDARD
LABELING; Labeling	SUPPL	24	AP	2001-07-31	STANDARD
LABELING; Labeling	SUPPL	26	AP	2005-01-12	STANDARD
LABELING; Labeling	SUPPL	27	AP	2007-07-13	STANDARD
LABELING; Labeling	SUPPL	29	AP	2012-10-26	STANDARD
LABELING; Labeling	SUPPL	30	AP	2014-07-10	901 REQUIRED
LABELING; Labeling	SUPPL	31	AP	2014-07-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	15

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18012
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088671.pdf"]
            [products] => [{"drugName":"PAMELOR","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 10MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/28\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018012s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2014","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018012s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-29","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-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018012s27lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/18012s026,18013s056lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2001","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/018012s24lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PAMELOR","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 10MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-07-28
        )

)