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01 3Accord healthcare

02 3Alkem Laboratories

03 2Apotex Inc

04 2Assia Chemical Industries Ltd

05 2Endo International

06 2Hetero Drugs

07 5Lupin Ltd

08 2MSN Laboratories

09 3ORIFARM GROUP AS

10 10Otsuka Australia Pharmaceutical

11 8Otsuka Chemical Co Ltd

12 12Otsuka Holdings

13 26Otsuka Pharmaceutical

14 3Teva Pharmaceutical Industries

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PharmaCompass

01

FCE Pharma
Not Confirmed
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FCE Pharma
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

FCE Pharma
Not Confirmed
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FCE Pharma
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

FCE Pharma
Not Confirmed
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FCE Pharma
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

FCE Pharma
Not Confirmed
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FCE Pharma
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

FCE Pharma
Not Confirmed
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FCE Pharma
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

FCE Pharma
Not Confirmed
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FCE Pharma
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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07

FCE Pharma
Not Confirmed
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FCE Pharma
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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08

FCE Pharma
Not Confirmed
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FCE Pharma
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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09

FCE Pharma
Not Confirmed
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FCE Pharma
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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10

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2025-04-23

Application Number : 216063

Regulatory Info : RX

Registration Country : USA

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11

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2025-04-23

Application Number : 216063

Regulatory Info : RX

Registration Country : USA

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12

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

TOLVAPTAN

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 45MG

Packaging :

Approval Date : 2025-04-23

Application Number : 216063

Regulatory Info : RX

Registration Country : USA

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13

FCE Pharma
Not Confirmed
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FCE Pharma
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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14

FCE Pharma
Not Confirmed
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FCE Pharma
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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15

FCE Pharma
Not Confirmed
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FCE Pharma
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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16

FCE Pharma
Not Confirmed
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FCE Pharma
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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17

FCE Pharma
Not Confirmed
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FCE Pharma
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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18

FCE Pharma
Not Confirmed
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FCE Pharma
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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19

FCE Pharma
Not Confirmed
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FCE Pharma
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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20

FCE Pharma
Not Confirmed
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FCE Pharma
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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