ANDA 078920

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078920

Application Sponsors

ANDA 078920

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 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	1MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
005	TABLET;ORAL	1.5MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE
006	TABLET;ORAL	0.75MG	0	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-07-06
LABELING; Labeling	SUPPL	4	AP	2012-05-15
LABELING; Labeling	SUPPL	5	AP	2013-11-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-11-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	18	Null	7

TE Codes

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

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78920
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAMIPEXOLE DIHYDROCHLORIDE","activeIngredients":"PRAMIPEXOLE DIHYDROCHLORIDE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAMIPEXOLE DIHYDROCHLORIDE","submission":"PRAMIPEXOLE DIHYDROCHLORIDE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)