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Approved Drug Products containing Eltrombopag listed in the FDA Orange Book. Original Data : FDA Website

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Product

Eltrombopag
FDA Orange Book

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Granules Eltrombopag

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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PharmaCompass Sponsored Ads

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Eltrombopag

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 17 USDMF, 5 EU WC, 12 NDC API, 30 Listed Suppliers, $ API Reference Price

40 API Suppliers
17 USDMF
5 EU WC
12 NDC API
30 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

17 API Suppliers

17 API Suppliers

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 25 FDA Orange Book, 10 Europe, 4 Canada, 16 Australia, 2 South Africa, 25 Listed Dossiers

82 FDF Dossiers
25 FDA Orange Book
10 Europe
4 Canada
16 Australia
2 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 12.5MG ACID, TABLET;ORAL - EQ 25MG ACID, TABLET;ORAL - EQ 50MG ACID, TABLET;ORAL - EQ 75MG ACID

TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 12.5MG ACID
TABLET;ORAL - EQ 25MG ACID
TABLET;ORAL - EQ 50MG ACID
TABLET;ORAL - EQ 75MG ACID

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 13 SPI Pharma, 5 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 3 DFE Pharma, 10 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 14 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Coating Systems & Additives, 49 Fillers, Diluents & Binders, 29 Direct Compression, 27 Controlled & Modified Release, 20 Thickeners and Stabilizers, 18 Solubilizers, 18 Disintegrants & Superdisintegrants, 16 Granulation, 14 Taste Masking, 13 Parenteral, 13 Lubricants & Glidants, 13 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 11 Film Formers & Plasticizers, 8 Topical, 7 API Stability Enhancers, 6 Rheology Modifiers, 5 Coloring Agents, 5 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

51 Coating Systems & Additives
49 Fillers, Diluents & Binders
29 Direct Compression
27 Controlled & Modified Release
20 Thickeners and Stabilizers
18 Solubilizers
18 Disintegrants & Superdisintegrants
16 Granulation
14 Taste Masking
13 Parenteral
13 Lubricants & Glidants
13 Co-Processed Excipients
12 Chewable & Orodispersible Aids
11 Film Formers & Plasticizers
8 Topical
7 API Stability Enhancers
6 Rheology Modifiers
5 Coloring Agents
5 Emulsifying Agents
5 Empty Capsules
4 Vegetarian Capsules
3 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 26 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
26 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices, 14 Annual Reports

1 US Medicaid Prescriptions
6 Finished Drug Prices
14 Annual Reports

MARKET PLACE

13 APIs, 7 FDF Dossiers

13 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

101 US Patents, 7 US Exclusivities, 9 Health Canada Patents

101 US Patents
7 US Exclusivities
9 Health Canada Patents

$ API Ref.Price (USD/KG) : 10,323 Xls

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01 1ACTAVIS LABS FL INC

02 4AMNEAL EU LTD

03 2ANNORA PHARMA

04 4HETERO LABS LTD V

05 7NOVARTIS

06 4TEVA PHARMS INC

07 3TEVA PHARMS USA INC

filter Dosage Reset all filters

25 All

01 4FOR SUSPENSION;ORAL

02 4TABLET; ORAL

03 17TABLET;ORAL

filter Regulatory Info Reset all filters

25 All

01 1DISCN

02 12RX

03 12Blank

filter Brand Name Reset all filters

25 All

01 4ALVAIZ

02 12ELTROMBOPAG

03 2ELTROMBOPAG OLAMINE

04 5PROMACTA

05 2PROMACTA KIT

filter RLD Reset all filters

25 All

01 2No

02 11Yes

03 12Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
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01

HETERO LABS LTD V

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HETERO LABS LTD V

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RLD :

TE Code :

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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02

HETERO LABS LTD V

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HETERO LABS LTD V

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RLD :

TE Code :

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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03

HETERO LABS LTD V

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HETERO LABS LTD V

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RLD :

TE Code :

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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04

HETERO LABS LTD V

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HETERO LABS LTD V

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RLD :

TE Code :

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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05

NOVARTIS

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RLD : Yes

TE Code :

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG ACID

Approval Date : 2008-11-20

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

NOVARTIS

Luxepack

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NOVARTIS

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RLD : Yes

TE Code :

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG ACID

Approval Date : 2008-11-20

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

NOVARTIS

Luxepack

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NOVARTIS

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RLD : Yes

TE Code :

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG ACID

Approval Date : 2009-09-08

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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08

NOVARTIS

Luxepack

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NOVARTIS

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RLD : Yes

TE Code :

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 12.5MG ACID

Approval Date : 2011-10-20

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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09

NOVARTIS

Luxepack

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NOVARTIS

Luxepack

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RLD : Yes

TE Code :

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2012-11-16

Application Number : 22291

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

NOVARTIS

Luxepack

Not Confirmed

NOVARTIS

Luxepack

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RLD : Yes

TE Code : AB

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA KIT

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 25MG ACID/PACKET

Approval Date : 2015-08-24

Application Number : 207027

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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