5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine
FDA Orange Book

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5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine

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ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 14 USDMF, 1 JDMF, 5 EU WC, 5 KDMF, 11 NDC API, 26 Listed Suppliers, $ API Reference Price

38 API Suppliers
14 USDMF
1 JDMF
5 EU WC
5 KDMF
11 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

64 Drugs in Development

64 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

44 FDF Dossiers, 10 FDA Orange Book, 19 Europe, 2 Canada, 6 Australia, 1 South Africa, 6 Listed Dossiers

44 FDF Dossiers
10 FDA Orange Book
19 Europe
2 Canada
6 Australia
1 South Africa
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 4 DKSH, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 2 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 11 BASF, 1 CD Formulation, 5 Corel Pharma Chem, 5 DFE Pharma, 10 Gangwal Chemicals, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 13 Kerry, 2 Keval Exports, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 11 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

35 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 17 Granulation, 17 Solubilizers, 16 Direct Compression, 15 Thickeners and Stabilizers, 15 Disintegrants & Superdisintegrants, 12 Controlled & Modified Release, 12 Lubricants & Glidants, 11 Parenteral, 9 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Topical, 5 Rheology Modifiers, 5 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 3 Taste Masking, 3 Surfactant & Foaming Agents, 2 Coloring Agents

35 Fillers, Diluents & Binders
20 Coating Systems & Additives
17 Granulation
17 Solubilizers
16 Direct Compression
15 Thickeners and Stabilizers
15 Disintegrants & Superdisintegrants
12 Controlled & Modified Release
12 Lubricants & Glidants
11 Parenteral
9 Co-Processed Excipients
7 Film Formers & Plasticizers
6 Topical
5 Rheology Modifiers
5 Emulsifying Agents
3 Chewable & Orodispersible Aids
3 API Stability Enhancers
3 Taste Masking
3 Surfactant & Foaming Agents
2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 44 News #PharmaBuzz

1 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
44 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 2 Regulatory FDF Prices, 9 Annual Reports

1 US Medicaid Prescriptions
2 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

8 APIs, 3 FDF Dossiers

8 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 2 US Exclusivities, 5 Health Canada Patents

10 US Patents
2 US Exclusivities
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 1 Others

3 USP
1 Others

$ API Ref.Price (USD/KG) : 11,086 Xls

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01 1ACTELION

02 1ALEMBIC

03 1APOTEX

04 1AUROBINDO PHARMA LTD

05 1LAURUS

06 1MSN

07 1RHODES PHARMS

08 1SUN PHARM

09 1TORRENT

10 1ZYDUS LIFESCIENCES

filter Dosage Reset all filters

10 All

01 10TABLET;ORAL

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01 4DISCN

02 5RX

03 1Blank

filter Brand Name Reset all filters

10 All

01 9MACITENTAN

02 1OPSUMIT

filter RLD Reset all filters

10 All

01 8No

02 1Yes

03 1Blank

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-08-18

Application Number : 211128

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2024-01-09

Application Number : 211195

RX/OTC/DISCN : DISCN

RLD : No

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RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2023-04-18

Application Number : 211198

RX/OTC/DISCN : DISCN

RLD : No

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RLD : Yes

TE Code : AB

Brand Name : OPSUMIT

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2013-10-18

Application Number : 204410

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-11-05

Application Number : 211120

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-08-20

Application Number : 211136

RX/OTC/DISCN : RX

RLD : No

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Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

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Application Number : 214112

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RLD : No

TE Code : AB

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2025-08-26

Application Number : 211123

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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TORRENT

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TORRENT

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RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2024-08-05

Application Number : 211107

RX/OTC/DISCN : DISCN

RLD : No

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ZYDUS LIFESCIENCES

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RLD : No

TE Code :

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2021-04-06

Application Number : 211224

RX/OTC/DISCN : DISCN

RLD : No

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