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

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Nilotinib Hydrochloride
FDA Orange Book

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Nilotinib Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 22 USDMF, 3 CEP/COS, 1 JDMF, 7 EU WC, 5 KDMF, 14 NDC API, 33 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

27 Intermediates Suppliers

27 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 10 FDA Orange Book, 6 Europe, 7 Australia, 2 South Africa, 23 Listed Dossiers

48 FDF Dossiers
10 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 Controlled & Modified Release, 1 API Stability Enhancers, 1 Taste Masking, 1 Solubilizers, 1 Topical

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 Controlled & Modified Release
1 API Stability Enhancers
1 Taste Masking
1 Solubilizers
1 Topical

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 42 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
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) : 4,825 Xls

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01 3APOTEX

02 2AZURITY

03 2MSN LABORATORIES PRIVATE LTD

04 3NOVARTIS

filter Dosage Reset all filters

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01 8CAPSULE;ORAL

02 2TABLET;ORAL

filter Regulatory Info Reset all filters

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01 3DISCN

02 3RX

03 4Blank

filter Brand Name Reset all filters

10 All

01 2DANZITEN

02 2NILOTINIB

03 3NILOTINIB HYDROCHLORIDE

04 3TASIGNA

filter RLD Reset all filters

10 All

01 3No

02 3Yes

03 4Blank

List of Suppliers

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01

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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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 :

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03

APOTEX

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APOTEX

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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 :

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04

AZURITY

Pharma, Lab & Chemical Expo

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AZURITY

Pharma, Lab & Chemical Expo

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RLD :

TE Code :

NILOTINIB TARTRATE

Brand Name : DANZITEN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 71MG BASE

Approval Date :

Application Number : 219293

RX/OTC/DISCN :

RLD :

TE Code :

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05

AZURITY

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AZURITY

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RLD :

TE Code :

NILOTINIB TARTRATE

Brand Name : DANZITEN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 95MG BASE

Approval Date :

Application Number : 219293

RX/OTC/DISCN :

RLD :

TE Code :

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06

MSN LABORATORIES PRIVATE LTD

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MSN LABORATORIES PRIVATE LTD

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RLD :

TE Code :

Brand Name : NILOTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date :

Application Number : 218544

RX/OTC/DISCN :

RLD :

TE Code :

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07

MSN LABORATORIES PRIVATE LTD

Pharma, Lab & Chemical Expo

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MSN LABORATORIES PRIVATE LTD

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RLD :

TE Code :

Brand Name : NILOTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date :

Application Number : 218544

RX/OTC/DISCN :

RLD :

TE Code :

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08

NOVARTIS

Pharma, Lab & Chemical Expo

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NOVARTIS

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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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09

NOVARTIS

Pharma, Lab & Chemical Expo

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NOVARTIS

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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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10

NOVARTIS

Pharma, Lab & Chemical Expo

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NOVARTIS

Pharma, Lab & Chemical Expo

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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 :

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