ANDA 202206

ANCHEN PHARMS

FDA Drug Application

Application #202206

Application Sponsors

ANDA 202206

ANCHEN PHARMS

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	2014-02-06
LABELING; Labeling	SUPPL	4	AP	2016-03-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-03-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-03-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-10-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	15
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	18	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

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202206
            [companyName] => ANCHEN PHARMS
            [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":"02\/06\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/19\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/28\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/28\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/28\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-19
        )

)