ANDA 206156

MACLEODS PHARMS LTD

FDA Drug Application

Application #206156

Application Sponsors

ANDA 206156

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	0.375MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	0.75MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	1.5MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	2.25MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	3MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	4.5MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	3.75MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-24	STANDARD
UNKNOWN;	ORIG	2	AP	2017-01-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-10-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	7
SUPPL	10	Null	15
SUPPL	16	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206156
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.375MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"2.25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"4.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"3.75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/23\/2017","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-23
        )

)