ANDA 087846

SPECGX LLC

FDA Drug Application

Application #087846

Documents

• Letter: 2013-03-13
• Label: 2013-03-12
• Label: 2014-09-05
• Other Important Information from FDA: 2007-05-09
• Medication Guide: 2018-11-08

Application Sponsors

ANDA 087846

SPECGX LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	0	TOFRANIL	IMIPRAMINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE
003	TABLET;ORAL	25MG	0	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-12-14
LABELING; Labeling	SUPPL	10	AP	1993-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-02-25
LABELING; Labeling	SUPPL	13	AP	1994-12-20
LABELING; Labeling	SUPPL	15	AP	1998-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-06-12
LABELING; Labeling	SUPPL	21	AP	2004-08-31
LABELING; Labeling	SUPPL	22	AP	2005-06-09
LABELING; Labeling	SUPPL	23	AP	2005-09-12
LABELING; Labeling	SUPPL	25	AP	2007-06-25
LABELING; Labeling	SUPPL	26	AP	2007-09-27
LABELING; Labeling	SUPPL	28	AP	2014-07-17	STANDARD
LABELING; Labeling	SUPPL	29	AP	2017-06-29	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	28	Null	7
SUPPL	29	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87846
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/087846s028,087844s027,087845s027lbl.pdf#page=3"]
            [products] => [{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOFRANIL","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/17\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/087846s028,087844s027,087845s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2007","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/087844s025,087845s025,087846s026pi.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TOFRANIL","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-07-17
        )

)