Nilotinib hydrochloride anhydrous | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Nilotinib Hydrochloride Anhydrous
FDA Orange Book

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Nilotinib hydrochloride anhydrous

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

48 API Suppliers, 22 USDMF, 3 CEP/COS, 1 JDMF, 7 EU WC, 5 KDMF, 14 NDC API, 34 Listed Suppliers, $ API Reference Price

48 API Suppliers
22 USDMF
3 CEP/COS
1 JDMF
7 EU WC
5 KDMF
14 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

27 Intermediates Suppliers

27 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

44 FDF Dossiers, 6 FDA Orange Book, 6 Europe, 7 Australia, 2 South Africa, 23 Listed Dossiers

44 FDF Dossiers
6 FDA Orange Book
6 Europe
7 Australia
2 South Africa
23 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 DKSH, 2 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 2 DFE Pharma, 2 Gangwal Chemicals, 14 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 2 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 1 Vasa Pharmachem

7 DKSH
2 Faran Shimi Pharmaceutical
4 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
4 ACG Worldwide
2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
2 DFE Pharma
2 Gangwal Chemicals
14 Kerry
3 Lonza Capsugel
7 Microlex e.U
1 Nanjing Bold Chemical
2 Pluviaendo
1 Prachin Chemical
1 Qualicaps
2 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
3 Sigachi Industries
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

30 Fillers, Diluents & Binders, 10 Lubricants & Glidants, 10 Direct Compression, 8 Empty Capsules, 7 Thickeners and Stabilizers, 5 Granulation, 5 Co-Processed Excipients, 5 Coating Systems & Additives, 4 Emulsifying Agents, 3 Film Formers & Plasticizers, 2 Coloring Agents, 2 Parenteral, 1 Topical, 1 Controlled & Modified Release, 1 API Stability Enhancers, 1 Taste Masking, 1 Solubilizers

30 Fillers, Diluents & Binders
10 Lubricants & Glidants
10 Direct Compression
8 Empty Capsules
7 Thickeners and Stabilizers
5 Granulation
5 Co-Processed Excipients
5 Coating Systems & Additives
4 Emulsifying Agents
3 Film Formers & Plasticizers
2 Coloring Agents
2 Parenteral
1 Topical
1 Controlled & Modified Release
1 API Stability Enhancers
1 Taste Masking
1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 42 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
42 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices, 10 Annual Reports

1 US Medicaid Prescriptions
3 Finished Drug Prices
10 Annual Reports

MARKET PLACE

9 APIs, 9 FDF Dossiers

9 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

45 US Patents, 18 US Exclusivities, 6 Health Canada Patents

45 US Patents
18 US Exclusivities
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 4,884 Xls

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01 3NILOTINIB HYDROCHLORIDE

02 3TASIGNA

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01 3No

02 3Yes

List of Suppliers

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01

APOTEX

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APOTEX

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Digital Content

RLD : No

TE Code :

NILOTINIB HYDROCHLORIDE

Brand Name : NILOTINIB HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2024-01-05

Application Number : 203640

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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02

APOTEX

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APOTEX

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Digital Content

RLD : No

TE Code :

NILOTINIB HYDROCHLORIDE

Brand Name : NILOTINIB HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2024-01-05

Application Number : 203640

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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03

APOTEX

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Not Confirmed

APOTEX

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Digital Content

RLD : No

TE Code :

NILOTINIB HYDROCHLORIDE

Brand Name : NILOTINIB HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2024-01-05

Application Number : 203640

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

NOVARTIS

Pharmtech & Ingredients

Not Confirmed

NOVARTIS

Pharmtech & Ingredients

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Digital Content

RLD : Yes

TE Code :

NILOTINIB HYDROCHLORIDE

Brand Name : TASIGNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2007-10-29

Application Number : 22068

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

NOVARTIS

Pharmtech & Ingredients

Not Confirmed

NOVARTIS

Pharmtech & Ingredients

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Digital Content

RLD : Yes

TE Code :

NILOTINIB HYDROCHLORIDE

Brand Name : TASIGNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2010-06-17

Application Number : 22068

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

NOVARTIS

Pharmtech & Ingredients

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NOVARTIS

Pharmtech & Ingredients

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Digital Content

RLD : Yes

TE Code :

NILOTINIB HYDROCHLORIDE

Brand Name : TASIGNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2018-03-22

Application Number : 22068

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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Digital Content

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