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
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 23 USDMF, 3 CEP/COS, 1 JDMF, 9 EU WC, 7 KDMF, 15 NDC API, 33 Listed Suppliers, $ API Reference Price

60 API Suppliers
23 USDMF
3 CEP/COS
1 JDMF
9 EU WC
7 KDMF
15 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

39 Intermediate Suppliers

39 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

60 FDF Dossiers, 16 FDA Orange Book, 6 Europe, 4 Canada, 7 Australia, 4 South Africa, 23 Listed Dossiers

60 FDF Dossiers
16 FDA Orange Book
6 Europe
4 Canada
7 Australia
4 South Africa
23 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 DKSH, 2 Faran Shimi Pharmaceutical, 2 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, 2 Sigachi Industries, 1 Silverline Chemicals, 1 Vasa Pharmachem

7 DKSH
2 Faran Shimi Pharmaceutical
2 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
2 Sigachi Industries
1 Silverline Chemicals
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

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

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

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 43 News #PharmaBuzz

2 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
43 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Regulatory FDF Prices, 11 Annual Reports

1 US Medicaid Prescriptions
3 Regulatory FDF Prices
11 Annual Reports

MARKET PLACE

9 APIs, 9 FDF Dossiers

9 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

46 US Patents
18 US Exclusivities
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 4,208 Xls

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16 All

01 3APOTEX

02 2AZURITY

03 3CIPLA

04 3HETERO LABS LIMITED

05 2MSN LABORATORIES PRIVATE LTD

06 3NOVARTIS

filter Dosage Reset all filters

16 All

01 3CAPSULE

02 11CAPSULE;ORAL

03 2TABLET;ORAL

filter Regulatory Info Reset all filters

16 All

01 11RX

02 5Blank

filter Brand Name Reset all filters

16 All

01 2DANZITEN

02 2NILOTINIB

03 3NILOTINIB D-TARTRATE

04 3NILOTINIB HYDROCHLORIDE

05 3NILOTINIB HYDROCHLORIDE DIHYDRATE

06 3TASIGNA

filter RLD Reset all filters

16 All

01 3No

02 8Yes

03 5Blank

List of Suppliers

Product Main Page

01

APOTEX

APS Symposium

Not Confirmed

APOTEX

APS Symposium

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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 : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

APOTEX

APS Symposium

Not Confirmed

APOTEX

APS Symposium

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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 : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

APOTEX

APS Symposium

Not Confirmed

APOTEX

APS Symposium

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

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 : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

HETERO LABS LIMITED

APS Symposium

Not Confirmed

HETERO LABS LIMITED

APS Symposium

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Digital Content

RLD :

TE Code :

NILOTINIB HYDROCHLORIDE DIHYDRATE

Brand Name : NILOTINIB HYDROCHLORIDE DIHYDRATE

Dosage Form : CAPSULE

Dosage Strength : 200MG

Approval Date :

Application Number : 209651

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

HETERO LABS LIMITED

APS Symposium

Not Confirmed

HETERO LABS LIMITED

APS Symposium

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Digital Content

RLD :

TE Code :

NILOTINIB HYDROCHLORIDE DIHYDRATE

Brand Name : NILOTINIB HYDROCHLORIDE DIHYDRATE

Dosage Form : CAPSULE

Dosage Strength : 50MG

Approval Date :

Application Number : 209651

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

HETERO LABS LIMITED

APS Symposium

Not Confirmed

HETERO LABS LIMITED

APS Symposium

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RLD :

TE Code :

NILOTINIB HYDROCHLORIDE DIHYDRATE

Brand Name : NILOTINIB HYDROCHLORIDE DIHYDRATE

Dosage Form : CAPSULE

Dosage Strength : 150MG

Approval Date :

Application Number : 209651

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

MSN LABORATORIES PRIVATE LTD

APS Symposium

Not Confirmed

MSN LABORATORIES PRIVATE LTD

APS Symposium

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Digital Content

RLD :

TE Code :

Brand Name : NILOTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date :

Application Number : 218544

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

Corporate PDF

08

NOVARTIS

APS Symposium

Not Confirmed

NOVARTIS

APS Symposium

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Digital Content

RLD : Yes

TE Code : AB

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 : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

NOVARTIS

APS Symposium

Not Confirmed

NOVARTIS

APS Symposium

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

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 : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

NOVARTIS

APS Symposium

Not Confirmed

NOVARTIS

APS Symposium

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code : AB

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 : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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