ANDA 084600

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084600

Application Sponsors

ANDA 084600

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

20MG

0

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1975-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1985-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1985-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1987-03-20
LABELING; Labeling	SUPPL	36	AP	1989-06-01
LABELING; Labeling	SUPPL	37	AP	1990-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1991-05-01
LABELING; Labeling	SUPPL	40	AP	1991-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1994-12-23
LABELING; Labeling	SUPPL	46	AP	1998-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1998-12-01

Submissions Property Types

SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84600
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICYCLOMINE HYDROCHLORIDE","submission":"DICYCLOMINE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)