ANDA 078110

PRINSTON INC

FDA Drug Application

Application #078110

Application Sponsors

ANDA 078110

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 0.25MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
002	TABLET;ORAL	EQ 0.5MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
003	TABLET;ORAL	EQ 1MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
004	TABLET;ORAL	EQ 2MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
005	TABLET;ORAL	EQ 3MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
006	TABLET;ORAL	EQ 4MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
007	TABLET;ORAL	EQ 5MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-05-05
LABELING; Labeling	SUPPL	6	AP	2015-12-11
LABELING; Labeling	SUPPL	9	AP	2015-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-12-11	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-02-21	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	14	Null	15
SUPPL	17	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

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78110
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 0.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 0.25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 3MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPINIROLE HYDROCHLORIDE","submission":"ROPINIROLE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)