ANDA 204518

ALEMBIC PHARMS LTD

FDA Drug Application

Application #204518

Application Sponsors

ANDA 204518

ALEMBIC 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	3.75MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	4.5MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-02

Submissions Property Types

ORIG

1

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

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204518
            [companyName] => ALEMBIC 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":"3.75MG","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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-02
        )

)