ANDA 091683

SUN PHARM INDS INC

FDA Drug Application

Application #091683

Application Sponsors

ANDA 091683

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET;ORAL	0.125MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
002	TABLET;ORAL	0.25MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
003	TABLET;ORAL	0.5MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
004	TABLET;ORAL	0.75MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
005	TABLET;ORAL	1MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
006	TABLET;ORAL	1.5MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-03-27
LABELING; Labeling	SUPPL	3	AP	2016-05-11	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	3	Null	15

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91683
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)