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01 2ABC Farmaceutici SpA

02 2Abdi Ibrahim

03 6Accord healthcare

04 4Actavis Inc

05 4Alembic Pharmaceuticals Limited

06 16Alphapharm PTY Ltd

07 2Alvogen

08 2Amneal Pharmaceuticals

09 12Apotex Inc

10 4Aurobindo Pharma Limited

11 2Centocor

12 2Chartwell Pharmaceuticals llc

13 12Dr Reddy's Laboratories (Australia) Pty Ltd

14 4Generic Health

15 2Helsinn Advanced Synthesis

16 2Hikma Pharmaceuticals

17 2Humanis

18 2Intas Pharmaceuticals

19 4Janssen-Cilag

20 11Johnson & Johnson Innovative Medicine

21 2Laboratorio Eczane Pharma

22 2Marklas Nederland BV

23 2Mepha Pharma

24 3Natco Pharma

25 2Natco Pharma (Canada) Inc

26 2PH HEALTH

27 2PharmFirma Sotex

28 4Pharmascience Inc.

29 2Pluviaendo

30 1Precise Group

31 2Sandoz B2B

32 16Sun Pharmaceutical Industries Limited

33 2Taro Pharmaceutical Industries

34 2Teva Pharmaceutical Industries

35 4Viatris

36 4World Medicine

37 2Zim Laboratories

38 3Zydus Pharmaceuticals

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PharmaCompass

01

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 207110

Regulatory Info : RX

Registration Country : USA

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02

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 207110

Regulatory Info : RX

Registration Country : USA

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03

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 206002

Regulatory Info : DISCN

Registration Country : USA

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04

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 206002

Regulatory Info : DISCN

Registration Country : USA

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05

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 209742

Regulatory Info : DISCN

Registration Country : USA

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06

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 208695

Regulatory Info : DISCN

Registration Country : USA

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07

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 208695

Regulatory Info : DISCN

Registration Country : USA

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08

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : TRACLEER

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2001-11-20

Application Number : 21290

Regulatory Info : RX

Registration Country : USA

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09

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : TRACLEER

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2001-11-20

Application Number : 21290

Regulatory Info : RX

Registration Country : USA

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10

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : TRACLEER

Dosage Form : TABLET, FOR SUSPENSION;ORAL

Dosage Strength : 32MG

Packaging :

Approval Date : 2017-09-05

Application Number : 209279

Regulatory Info : RX

Registration Country : USA

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11

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 206987

Regulatory Info : DISCN

Registration Country : USA

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12

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 206987

Regulatory Info : DISCN

Registration Country : USA

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13

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 209324

Regulatory Info : RX

Registration Country : USA

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14

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 209324

Regulatory Info : RX

Registration Country : USA

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15

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2020-01-15

Application Number : 205173

Regulatory Info : DISCN

Registration Country : USA

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16

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2020-01-15

Application Number : 205173

Regulatory Info : DISCN

Registration Country : USA

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17

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 207760

Regulatory Info : RX

Registration Country : USA

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18

iPHEX India
Not Confirmed
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 207760

Regulatory Info : RX

Registration Country : USA

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19

PH HEALTH

Country
iPHEX India
Not Confirmed
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PH HEALTH

Country
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iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 62.5MG

Packaging :

Approval Date : 2019-04-26

Application Number : 205699

Regulatory Info : DISCN

Registration Country : USA

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20

PH HEALTH

Country
iPHEX India
Not Confirmed
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PH HEALTH

Country
arrow
iPHEX India
Not Confirmed

BOSENTAN

Brand Name : BOSENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2019-04-26

Application Number : 205699

Regulatory Info : DISCN

Registration Country : USA

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