ANDA 084505

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084505

Application Sponsors

ANDA 084505

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

10MG

0

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1975-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1986-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1986-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1986-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1986-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1987-03-20
LABELING; Labeling	SUPPL	49	AP	1989-06-08
LABELING; Labeling	SUPPL	51	AP	1990-10-31
LABELING; Labeling	SUPPL	53	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1994-12-23
LABELING; Labeling	SUPPL	59	AP	1998-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1998-12-01

Submissions Property Types

SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	54	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	60	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84505
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICYCLOMINE HYDROCHLORIDE","submission":"DICYCLOMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)