CAS-142217-69-4 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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CAS-142217-69-4
FDA Orange Book

Evonik

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Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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xyz-pharma-m-2025-04-21

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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xyz-pharma-m-2025-04-14

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CAS-142217-69-4

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 18 USDMF, 9 CEP/COS, 11 JDMF, 3 EU WC, 13 KDMF, 11 NDC API, 26 Listed Suppliers, $ API Reference Price

49 API Suppliers
18 USDMF
9 CEP/COS
11 JDMF
3 EU WC
13 KDMF
11 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers, 39 FDA Orange Book, 42 Europe, 7 Canada, 12 Australia, 2 South Africa, 32 Listed Dossiers

134 FDF Dossiers
39 FDA Orange Book
42 Europe
7 Canada
12 Australia
2 South Africa
32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG, TABLET;ORAL - 1MG, SOLUTION;ORAL - 0.05MG/ML

TABLET;ORAL - 0.5MG
TABLET;ORAL - 1MG
SOLUTION;ORAL - 0.05MG/ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 17 SPI Pharma, 5 DKSH, 5 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 24 BASF, 2 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 33 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

82 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 35 Disintegrants & Superdisintegrants, 34 Direct Compression, 32 Thickeners and Stabilizers, 30 Controlled & Modified Release, 26 Solubilizers, 24 Granulation, 20 Taste Masking, 19 Chewable & Orodispersible Aids, 17 Parenteral, 16 Film Formers & Plasticizers, 16 Topical, 16 Lubricants & Glidants, 15 Co-Processed Excipients, 8 Emulsifying Agents, 6 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents

82 Fillers, Diluents & Binders
54 Coating Systems & Additives
35 Disintegrants & Superdisintegrants
34 Direct Compression
32 Thickeners and Stabilizers
30 Controlled & Modified Release
26 Solubilizers
24 Granulation
20 Taste Masking
19 Chewable & Orodispersible Aids
17 Parenteral
16 Film Formers & Plasticizers
16 Topical
16 Lubricants & Glidants
15 Co-Processed Excipients
8 Emulsifying Agents
6 API Stability Enhancers
6 Rheology Modifiers
5 Empty Capsules
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 25 News #PharmaBuzz

1 Data Compilation #PharmaFlow
25 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 36 Regulatory FDF Prices, 7 Annual Reports

2 US Medicaid Prescriptions
36 Regulatory FDF Prices
7 Annual Reports

MARKET PLACE

13 APIs, 7 FDF Dossiers

13 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 3 Others

1 EDQM
3 Others

ANALYTICAL

4 BioAnalytical Methods

4 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 267,745 Xls

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39 All

01 2BRECKENRIDGE

02 2ACCORD HLTHCARE

03 2AMNEAL PHARMS

04 2AUROBINDO PHARMA

05 2BRIGHTGENE

06 3BRISTOL MYERS SQUIBB

07 4CHARTWELL RX

08 2CIPLA

09 2CONBA USA

10 2HETERO LABS LTD V

11 2PRINSTON INC

12 2RISING

13 2SUNSHINE

14 2SWISS PHARM

15 2TEVA PHARMS USA

16 2YAOPHARMA CO LTD

17 2YUNG SHIN PHARM

18 2ZYDUS PHARMS

filter Dosage Reset all filters

39 All

01 1SOLUTION;ORAL

02 38TABLET;ORAL

filter Regulatory Info Reset all filters

39 All

01 18DISCN

02 21RX

filter Brand Name Reset all filters

39 All

01 3BARACLUDE

02 36ENTECAVIR

filter RLD Reset all filters

39 All

01 36No

02 3Yes

List of Suppliers

Product Main Page

01

BRECKENRIDGE

AACR Annual meeting

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Digital Content

RLD : No

TE Code : AB

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2018-03-15

Application Number : 208721

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

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02

BRECKENRIDGE

AACR Annual meeting

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Digital Content

RLD : No

TE Code : AB

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2018-03-15

Application Number : 208721

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

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03

ACCORD HLTHCARE

AACR Annual meeting

Not Confirmed

ACCORD HLTHCARE

AACR Annual meeting

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RLD : No

TE Code :

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2017-08-25

Application Number : 205824

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

BRISTOL MYERS SQUIBB

AACR Annual meeting

Not Confirmed

BRISTOL MYERS SQUIBB

AACR Annual meeting

Not Confirmed

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RLD : Yes

TE Code : AB

Brand Name : BARACLUDE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2005-03-29

Application Number : 21797

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

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05

BRISTOL MYERS SQUIBB

AACR Annual meeting

Not Confirmed

BRISTOL MYERS SQUIBB

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : BARACLUDE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2005-03-29

Application Number : 21797

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

BRISTOL MYERS SQUIBB

AACR Annual meeting

Not Confirmed

BRISTOL MYERS SQUIBB

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

Brand Name : BARACLUDE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.05MG/ML

Approval Date : 2005-03-29

Application Number : 21798

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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07

HETERO LABS LTD V

AACR Annual meeting

Not Confirmed

HETERO LABS LTD V

AACR Annual meeting

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Digital Content

RLD : No

TE Code : AB

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2015-08-21

Application Number : 205740

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

HETERO LABS LTD V

AACR Annual meeting

Not Confirmed

HETERO LABS LTD V

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2015-08-21

Application Number : 205740

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

TEVA PHARMS USA

AACR Annual meeting

Not Confirmed

TEVA PHARMS USA

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2014-08-26

Application Number : 202122

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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10

TEVA PHARMS USA

AACR Annual meeting

Not Confirmed

TEVA PHARMS USA

AACR Annual meeting

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2014-08-26

Application Number : 202122

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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