ANDA 081048

SUN PHARM INDUSTRIES

FDA Drug Application

Application #081048

Application Sponsors

ANDA 081048

SUN PHARM INDUSTRIES

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

IMIPRAMINE HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1990-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-06-22
LABELING; Labeling	SUPPL	4	AP	1995-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-12-05
LABELING; Labeling	SUPPL	7	AP	1999-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-10-02
LABELING; Labeling	SUPPL	11	AP	2000-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-04-02
LABELING; Labeling	SUPPL	21	AP	2005-05-05
LABELING; Labeling	SUPPL	22	AP	2005-12-02
LABELING; Labeling	SUPPL	26	AP	2007-06-26
LABELING; Labeling	SUPPL	27	AP	2007-10-19
LABELING; Labeling	SUPPL	28	AP	2007-10-19
LABELING; Labeling	SUPPL	31	AP	2014-09-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2016-02-02	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	31	Null	7
SUPPL	33	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81048
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)