ANDA 204413

PRINSTON INC

FDA Drug Application

Application #204413

Application Sponsors

ANDA 204413

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 6MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	EQ 12MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-11

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204413
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-11
        )

)