ANDA 079050

CELLTRION

FDA Drug Application

Application #079050

Application Sponsors

ANDA 079050

CELLTRION

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	2008-05-29
LABELING; Labeling	SUPPL	2	AP	2011-11-07
LABELING; Labeling	SUPPL	3	AP	2013-01-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-03-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-12-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-10-26	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	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

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79050
            [companyName] => CELLTRION
            [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
        )

)