ANDA 201576

DR REDDYS LABS LTD

FDA Drug Application

Application #201576

Application Sponsors

ANDA 201576

DR REDDYS LABS LTD

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

N/A; Not Applicable

ORIG

1

AP

2012-06-06

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201576
            [companyName] => DR REDDYS LABS LTD
            [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":"06\/06\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/19\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-10-19
        )

)