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01 3Accord healthcare

02 3Alkem Laboratories

03 2Apotex Inc

04 2Assia Chemical Industries Ltd

05 2ENDO OPERATIONS

06 2Hetero Drugs

07 2MSN Laboratories

08 3ORIFARM GROUP AS

09 10Otsuka Australia Pharmaceutical

10 8Otsuka Chemical Co Ltd

11 12Otsuka Holdings

12 26Otsuka Pharmaceutical

13 3Teva Pharmaceutical Industries

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PharmaCompass

01

Cosmoprof
Not Confirmed
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arrow
Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2020-05-19

Application Number : 211891

Regulatory Info : RX

Registration Country : USA

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02

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG

Packaging :

Approval Date : 2020-05-19

Application Number : 211891

Regulatory Info : RX

Registration Country : USA

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03

Cosmoprof
Not Confirmed
arrow
arrow
Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2022-09-06

Application Number : 211891

Regulatory Info : RX

Registration Country : USA

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04

Cosmoprof
Not Confirmed
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arrow
Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2020-05-19

Application Number : 207605

Regulatory Info : RX

Registration Country : USA

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05

Cosmoprof
Not Confirmed
arrow
arrow
Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2022-09-06

Application Number : 207605

Regulatory Info : RX

Registration Country : USA

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06

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2021-07-16

Application Number : 205646

Regulatory Info : RX

Registration Country : USA

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07

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2022-09-06

Application Number : 205646

Regulatory Info : RX

Registration Country : USA

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08

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2023-06-21

Application Number : 216949

Regulatory Info : RX

Registration Country : USA

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09

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2023-06-21

Application Number : 216949

Regulatory Info : RX

Registration Country : USA

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10

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : SAMSCA

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2009-05-19

Application Number : 22275

Regulatory Info : RX

Registration Country : USA

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11

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : SAMSCA

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2009-05-19

Application Number : 22275

Regulatory Info : RX

Registration Country : USA

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12

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : SAMSCA

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2009-05-19

Application Number : 22275

Regulatory Info : DISCN

Registration Country : USA

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13

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2018-04-23

Application Number : 204441

Regulatory Info : RX

Registration Country : USA

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14

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2018-04-23

Application Number : 204441

Regulatory Info : RX

Registration Country : USA

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15

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 45MG

Packaging :

Approval Date : 2018-04-23

Application Number : 204441

Regulatory Info : RX

Registration Country : USA

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16

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG

Packaging :

Approval Date : 2018-04-23

Application Number : 204441

Regulatory Info : RX

Registration Country : USA

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17

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 90MG

Packaging :

Approval Date : 2018-04-23

Application Number : 204441

Regulatory Info : RX

Registration Country : USA

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18

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Jinarc

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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19

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Jinarc

Dosage Form : TABLET

Dosage Strength : 45 MG + 15 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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20

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Jinarc

Dosage Form : TABLET

Dosage Strength : 90 MG + 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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21

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Jinarc

Dosage Form : TABLET

Dosage Strength : 60 MG + 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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22

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Jinarc

Dosage Form : TABLET

Dosage Strength : 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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23

Cosmoprof
Not Confirmed
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arrow
Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Samsca

Dosage Form : TABLET

Dosage Strength : 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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24

Cosmoprof
Not Confirmed
arrow
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Cosmoprof
Not Confirmed

tolvaptan

Brand Name : Samsca

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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25

Cosmoprof
Not Confirmed
arrow
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Cosmoprof
Not Confirmed

Tolvaptan

Brand Name : Samsca

Dosage Form : Tolvaptan 15Mg 10 Units Oral Use

Dosage Strength : 10 CPR 15 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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26

Cosmoprof
Not Confirmed
arrow
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Cosmoprof
Not Confirmed

Tolvaptan

Brand Name : Samsca

Dosage Form : Tolvaptan 30Mg 10 Units Oral Use

Dosage Strength : 10 CPR 30 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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27

Cosmoprof
Not Confirmed
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Cosmoprof
Not Confirmed

Tolvaptan

Brand Name : Jinarc

Dosage Form :

Dosage Strength :

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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28

Cosmoprof
Not Confirmed
arrow
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Cosmoprof
Not Confirmed

Tolvaptan

Brand Name : Jinarc

Dosage Form :

Dosage Strength :

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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29

ENDO OPERATIONS

Country
Cosmoprof
Not Confirmed
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ENDO OPERATIONS

Country
arrow
Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2022-02-15

Application Number : 206119

Regulatory Info : RX

Registration Country : USA

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30

ENDO OPERATIONS

Country
Cosmoprof
Not Confirmed
arrow

ENDO OPERATIONS

Country
arrow
Cosmoprof
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2022-02-15

Application Number : 206119

Regulatory Info : RX

Registration Country : USA

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