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01 2ADVANZ PHARMA CANADA INC.

02 6Advanz Pharma

03 2Apotex Inc

04 3Chiesi Australia

05 3Intas Pharmaceuticals

06 2Intercept Pharma Ltd.

07 2Intercept Pharmaceuticals

08 2Lupin Ltd

09 2MSN Laboratories

10 1Optimus Pharma

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholic Acid

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 01/06/2018

Application Number : 66530

Regulatory Info : Allowed

Registration Country : Switzerland

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholic Acid

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 01/06/2018

Application Number : 66530

Regulatory Info : Allowed

Registration Country : Switzerland

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholsyra

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 12/12/2016

Application Number : 20150613000028

Regulatory Info : Deregistered

Registration Country : Sweden

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholsyra

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 12/12/2016

Application Number : 20150613000011

Regulatory Info : Deregistered

Registration Country : Sweden

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214862

Regulatory Info : DISCN

Registration Country : USA

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214862

Regulatory Info : DISCN

Registration Country : USA

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2016-05-27

Application Number : 207999

Regulatory Info : RX

Registration Country : USA

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2016-05-27

Application Number : 207999

Regulatory Info : RX

Registration Country : USA

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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214980

Regulatory Info : DISCN

Registration Country : USA

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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214980

Regulatory Info : DISCN

Registration Country : USA

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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 215017

Regulatory Info : DISCN

Registration Country : USA

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15

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 215017

Regulatory Info : DISCN

Registration Country : USA

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16

FNCE
Not Confirmed
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET; ORAL

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number : 214935

Regulatory Info :

Registration Country : USA

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17

Intercept Pharma Ltd.

Country
FNCE
Not Confirmed
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Intercept Pharma Ltd.

Country
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FNCE
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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18

Intercept Pharma Ltd.

Country
FNCE
Not Confirmed
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Intercept Pharma Ltd.

Country
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FNCE
Not Confirmed

obeticholic acid

Brand Name : Ocaliva

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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19

ADVANZ PHARMA CANADA INC.

Country
FNCE
Not Confirmed
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ADVANZ PHARMA CANADA INC.

Country
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2463121

Regulatory Info : Prescription

Registration Country : Canada

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20

ADVANZ PHARMA CANADA INC.

Country
FNCE
Not Confirmed
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ADVANZ PHARMA CANADA INC.

Country
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FNCE
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2463148

Regulatory Info : Prescription

Registration Country : Canada

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