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Zetia
FDA Orange Book

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pharmacompass-2-m-2026-04-20

Zetia

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

145 API Suppliers, 32 USDMF, 11 JDMF, 20 EU WC, 92 KDMF, 15 NDC API, 45 Listed Suppliers

145 API Suppliers
32 USDMF
11 JDMF
20 EU WC
92 KDMF
15 NDC API
45 Listed Suppliers

DEVELOPMENTS

60 Drugs in Development

60 Drugs in Development

INTERMEDIATES

32 Intermediate Suppliers

32 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1236 FDF Dossiers, 71 FDA Orange Book, 857 Europe, 20 Canada, 135 Australia, 49 South Africa, 104 Listed Dossiers

1236 FDF Dossiers
71 FDA Orange Book
857 Europe
20 Canada
135 Australia
49 South Africa
104 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 10MG
TABLET;ORAL - 10MG;10MG
TABLET;ORAL - 10MG;20MG
TABLET;ORAL - 10MG;40MG
TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 6 SPI Pharma, 5 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 3 Kirsch Pharma, 1 Panvo Organics, 1 Cerata Pharmaceuticals LLP, 3 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 19 BASF, 2 CD Formulation, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 1 Gloria Interchem, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Pharmachem, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders, 40 Coating Systems & Additives, 39 Disintegrants & Superdisintegrants, 34 Direct Compression, 32 Granulation, 22 Lubricants & Glidants, 20 Thickeners and Stabilizers, 19 Controlled & Modified Release, 12 Chewable & Orodispersible Aids, 11 Co-Processed Excipients, 10 Taste Masking, 10 Solubilizers, 8 Film Formers & Plasticizers, 8 API Stability Enhancers, 6 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents, 2 Topical, 1 Surfactant & Foaming Agents

51 Fillers, Diluents & Binders
40 Coating Systems & Additives
39 Disintegrants & Superdisintegrants
34 Direct Compression
32 Granulation
22 Lubricants & Glidants
20 Thickeners and Stabilizers
19 Controlled & Modified Release
12 Chewable & Orodispersible Aids
11 Co-Processed Excipients
10 Taste Masking
10 Solubilizers
8 Film Formers & Plasticizers
8 API Stability Enhancers
6 Parenteral
5 Empty Capsules
4 Vegetarian Capsules
4 Emulsifying Agents
3 Rheology Modifiers
2 Coloring Agents
2 Topical
1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 Weekly News Recap #Phispers, 121 News #PharmaBuzz

3 Weekly News Recap #Phispers
121 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 160 Regulatory FDF Prices, 65 Annual Reports

28 US Medicaid Prescriptions
160 Regulatory FDF Prices
65 Annual Reports

MARKET PLACE

27 APIs, 5 FDF Dossiers

27 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

21 US Patents, 2 US Exclusivities, 2 Health Canada Patents

21 US Patents
2 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 4 Others

4 USP
4 Others

ANALYTICAL

6 BioAnalytical Methods

6 BioAnalytical Methods

Xls

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FILTER :

filter Applicant Reset all filters

71 All

01 1ACCORD HLTHCARE

02 1ALKEM LABORATORIES LIMITED

03 5ALKEM LABS LTD

04 4ALTHERA PHARMS

05 5AMNEAL PHARMS CO

06 4ANI PHARMS

07 1APOTEX

08 1AUROBINDO PHARMA

09 4AUROBINDO PHARMA USA

10 4DR REDDYS LABS SA

11 1ESPERION THERAPS INC

12 5GLENMARK PHARMS LTD

13 1HETERO LABS LTD III

14 1MACLEODS PHARMS LTD

15 1OHM LABS INC

16 9ORGANON

17 1ORIENT PHARMA

18 4PHARMOBEDIENT

19 1RISING

20 1SANDOZ

21 5SCIEGEN PHARMS

22 1TEVA PHARMS USA

23 4TORRENT

24 5WATSON LABS INC

25 1ZYDUS PHARMS

filter Dosage Reset all filters

71 All

01 1TABLET

02 70TABLET;ORAL

filter Regulatory Info Reset all filters

71 All

01 32DISCN

02 38RX

03 1Blank

filter Brand Name Reset all filters

71 All

01 1BEMPEDOIC ACID AND EZETIMIBE

02 16EZETIMIBE

03 36EZETIMIBE AND SIMVASTATIN

04 4LIPTRUZET

05 4LYPQOZET

06 1NEXLIZET

07 4ROSZET

08 4VYTORIN

09 1ZETIA

filter RLD Reset all filters

71 All

01 56No

02 14Yes

03 1Blank

List of Suppliers

Product Main Page

01

AUROBINDO PHARMA USA

PEGS Boston Summit

Not Confirmed

AUROBINDO PHARMA USA

PEGS Boston Summit

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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RLD : No

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;10MG

Approval Date : 2020-12-17

Application Number : 200082

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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02

AUROBINDO PHARMA USA

PEGS Boston Summit

Not Confirmed

AUROBINDO PHARMA USA

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;20MG

Approval Date : 2020-12-17

Application Number : 200082

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

AUROBINDO PHARMA USA

PEGS Boston Summit

Not Confirmed

AUROBINDO PHARMA USA

PEGS Boston Summit

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Digital Content

RLD : No

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;40MG

Approval Date : 2020-12-17

Application Number : 200082

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

GLENMARK PHARMS LTD

PEGS Boston Summit

Not Confirmed

GLENMARK PHARMS LTD

PEGS Boston Summit

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Digital Content

RLD : No

TE Code : AB

Brand Name : EZETIMIBE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2015-06-26

Application Number : 78560

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Digital Content

Corporate PDF

05

ORGANON

PEGS Boston Summit

Not Confirmed

ORGANON

PEGS Boston Summit

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : ZETIA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2002-10-25

Application Number : 21445

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

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06

ORGANON

PEGS Boston Summit

Not Confirmed

ORGANON

PEGS Boston Summit

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Digital Content

RLD : Yes

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : VYTORIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;10MG

Approval Date : 2004-07-23

Application Number : 21687

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

ORGANON

PEGS Boston Summit

Not Confirmed

ORGANON

PEGS Boston Summit

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Digital Content

RLD : Yes

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : VYTORIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;20MG

Approval Date : 2004-07-23

Application Number : 21687

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

ORGANON

PEGS Boston Summit

Not Confirmed

ORGANON

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : VYTORIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;40MG

Approval Date : 2004-07-23

Application Number : 21687

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

ORGANON

PEGS Boston Summit

Not Confirmed

ORGANON

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

EZETIMIBE; SIMVASTATIN

Brand Name : VYTORIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;80MG

Approval Date : 2004-07-23

Application Number : 21687

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

TEVA PHARMS USA

PEGS Boston Summit

Not Confirmed

TEVA PHARMS USA

PEGS Boston Summit

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : EZETIMIBE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2017-06-12

Application Number : 78724

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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