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01 12Accord healthcare

02 10Actavis Inc

03 12Alembic Pharmaceuticals Limited

04 11Aurobindo Pharma Limited

05 12Chartwell Pharmaceuticals llc

06 5Cinfa

07 7Cosette Pharma

08 3DOC Generici

09 8EG SpA

10 5Elite Laboratories

11 7Epic Pharma. LLC.

12 24GSK

13 7Glenmark Pharmaceuticals

14 7Hikma Pharmaceuticals

15 8Kern Pharma S.L.

16 9Krka

17 8LABORATOIRE GLAXOSMITHKLINE

18 4LABORATORIOS NORMON SA

19 7MLV

20 7OrBion Pharmaceuticals

21 7Orchid Pharma

22 7PHARMOBEDIENT

23 4Pharmascience Inc.

24 12Prinston

25 3STADA Arzneimittel

26 11Sandoz B2B

27 4Sun Pharmaceutical Industries Limited

28 5Tarbis Farma Sl

29 13Teva Pharmaceutical Industries

30 5Viatris

31 5XYZ Pharma

32 7Zydus Lifesciences

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Ropinirole HCI

Brand Name : Accord Ropinirole 5 mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 84X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : ROPINIROLE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.25MG BASE

Packaging :

Approval Date : 2008-05-05

Application Number : 77460

Regulatory Info : DISCN

Registration Country : USA

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : ROPINIROLE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2008-05-05

Application Number : 77460

Regulatory Info : DISCN

Registration Country : USA

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04

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : ROPINIROLE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2008-05-05

Application Number : 77460

Regulatory Info : DISCN

Registration Country : USA

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05

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : ROPINIROLE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE

Packaging :

Approval Date : 2008-05-05

Application Number : 77460

Regulatory Info : DISCN

Registration Country : USA

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06

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : ROPINIROLE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 3MG BASE

Packaging :

Approval Date : 2008-05-05

Application Number : 77460

Regulatory Info : DISCN

Registration Country : USA

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07

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : ROPINIROLE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE

Packaging :

Approval Date : 2008-05-05

Application Number : 77460

Regulatory Info : DISCN

Registration Country : USA

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-09-19

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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09

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-09-19

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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10

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-09-19

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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11

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-09-19

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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12

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1997-09-19

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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13

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1999-01-27

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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14

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1999-01-27

Application Number : 20658

Regulatory Info : DISCN

Registration Country : USA

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15

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-06-13

Application Number : 22008

Regulatory Info : DISCN

Registration Country : USA

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16

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-06-13

Application Number : 22008

Regulatory Info : DISCN

Registration Country : USA

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17

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-06-13

Application Number : 22008

Regulatory Info : DISCN

Registration Country : USA

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18

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-06-13

Application Number : 22008

Regulatory Info : DISCN

Registration Country : USA

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19

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2008-10-31

Application Number : 22008

Regulatory Info : DISCN

Registration Country : USA

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20

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

ROPINIROLE HYDROCHLORIDE

Brand Name : REQUIP XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2009-04-10

Application Number : 22008

Regulatory Info : DISCN

Registration Country : USA

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