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01 1AGGREGA PHARMA, LLC

02 1APPCO PHARMA LLC

03 2Amdipharm Mercury Company Limited

04 2Apotex Inc

05 2Assia Chemical Industries Ltd

06 2JAMP PHARMA

07 2Kolmar Korea Co., Ltd.

08 2Laboratorio Eczane Pharma

09 2Medichem S.A

10 2Mirpharm

11 2Nora Pharma

12 2Novitium Pharma LLC

13 2Razi Al Madina Pharmaceuticals

14 8SHIRE PLC

15 2SKG-Pharma

16 4Takeda Pharmaceutical

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PharmaCompass

01

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE

Brand Name : PRUCALOPRIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 219071

Regulatory Info :

Registration Country : USA

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02

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE

Brand Name : PRUCALOPRIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number : 219071

Regulatory Info :

Registration Country : USA

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03

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Prucalopride succinate

Brand Name : Prusolo Tablet

Dosage Form : Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : South Korea

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04

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Prucalopride succinate

Brand Name : Prusolo Tablet

Dosage Form : Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : South Korea

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05

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE SUCCINATE

Brand Name : PRUCALOPRIDE SUCCINATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2024-12-26

Application Number : 218492

Regulatory Info : RX

Registration Country : USA

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06

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE SUCCINATE

Brand Name : PRUCALOPRIDE SUCCINATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE

Packaging :

Approval Date : 2024-12-26

Application Number : 218492

Regulatory Info : RX

Registration Country : USA

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07

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

prukalopridsuccinat

Brand Name : Resolor

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 1 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

prukalopridsuccinat

Brand Name : Resolor

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 2 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Prucalopride

Brand Name : Resolor

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 1 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Prucalopride

Brand Name : Resolor

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 1 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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11

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Prucalopride

Brand Name : Resolor

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 1 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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12

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Prucalopride

Brand Name : Resolor

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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13

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Prucalopride

Brand Name : Resolor

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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14

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Prucalopride

Brand Name : Resolor

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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15

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE

Brand Name : PRUCALOPRIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 218812

Regulatory Info :

Registration Country : USA

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16

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE

Brand Name : PRUCALOPRIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number : 218812

Regulatory Info :

Registration Country : USA

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17

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE SUCCINATE

Brand Name : MOTEGRITY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2018-12-14

Application Number : 210166

Regulatory Info : RX

Registration Country : USA

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18

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE SUCCINATE

Brand Name : MOTEGRITY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE

Packaging :

Approval Date : 2018-12-14

Application Number : 210166

Regulatory Info : RX

Registration Country : USA

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19

APPCO PHARMA LLC

Country
AMWC Asia-TDAC
Not Confirmed
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APPCO PHARMA LLC

Country
arrow
AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE

Brand Name : PRUCALOPRIDE

Dosage Form : TABLET

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 218963

Regulatory Info :

Registration Country : USA

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20

AGGREGA PHARMA, LLC

Country
AMWC Asia-TDAC
Not Confirmed
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AGGREGA PHARMA, LLC

Country
arrow
AMWC Asia-TDAC
Not Confirmed

PRUCALOPRIDE SUCCINATE

Brand Name : PRUCALOPRIDE SUCCINATE

Dosage Form : TABLET; FILM COATED

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 219193

Regulatory Info :

Registration Country : USA

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