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Approved Drug Products containing Ranolazine listed in the FDA Orange Book. Original Data : FDA Website

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Product

Ranolazine
CAS 2210-74-4
CAS 5294-61-1
FDA Orange Book

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Ranolazine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

56 API Suppliers, 28 USDMF, 16 EU WC, 1 KDMF, 22 NDC API, 39 Listed Suppliers, $ API Reference Price

56 API Suppliers
28 USDMF
16 EU WC
1 KDMF
22 NDC API
39 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

16 API Suppliers

16 API Suppliers

FINISHED DOSAGE FORMULATIONS

109 FDF Dossiers, 54 FDA Orange Book, 28 Europe, 2 Canada, 3 South Africa, 22 Listed Dossiers

109 FDF Dossiers
54 FDA Orange Book
28 Europe
2 Canada
3 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GRANULES, EXTENDED RELEASE;ORAL - 1GM, GRANULES, EXTENDED RELEASE;ORAL - 500MG

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GRANULES, EXTENDED RELEASE;ORAL - 1GM
GRANULES, EXTENDED RELEASE;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 1 SPI Pharma, 2 DKSH, 1 Jai Radhe Sales, 8 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Clariant, 13 Corel Pharma Chem, 4 DFE Pharma, 10 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 12 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Coating Systems & Additives, 44 Fillers, Diluents & Binders, 32 Controlled & Modified Release, 20 Direct Compression, 14 Solubilizers, 14 Thickeners and Stabilizers, 13 Lubricants & Glidants, 12 Film Formers & Plasticizers, 12 Co-Processed Excipients, 10 Granulation, 9 Parenteral, 7 Disintegrants & Superdisintegrants, 7 Topical, 6 Taste Masking, 5 Empty Capsules, 5 API Stability Enhancers, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 3 Surfactant & Foaming Agents, 3 Chewable & Orodispersible Aids

62 Coating Systems & Additives
44 Fillers, Diluents & Binders
32 Controlled & Modified Release
20 Direct Compression
14 Solubilizers
14 Thickeners and Stabilizers
13 Lubricants & Glidants
12 Film Formers & Plasticizers
12 Co-Processed Excipients
10 Granulation
9 Parenteral
7 Disintegrants & Superdisintegrants
7 Topical
6 Taste Masking
5 Empty Capsules
5 API Stability Enhancers
5 Emulsifying Agents
4 Vegetarian Capsules
4 Coloring Agents
4 Rheology Modifiers
3 Surfactant & Foaming Agents
3 Chewable & Orodispersible Aids

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices, 8 Annual Reports

1 US Medicaid Prescriptions
25 Finished Drug Prices
8 Annual Reports

MARKET PLACE

17 APIs, 2 FDF Dossiers

17 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents

3 US Patents

REF. STANDARDS & IMPURITIES

4 USP, 9 Others

4 USP
9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 84 Xls

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54 All

01 2ACCORD HLTHCARE

02 2ACTAVIS ELIZABETH

03 2AJANTA PHARMA LTD

04 2ALKEM LABS LTD

05 2AMNEAL

06 2ANI PHARMS

07 2AUROBINDO PHARMA

08 2CADILA

09 2CHARTWELL RX

10 2CIPLA

11 2GLENMARK PHARMS LTD

12 2HETERO LABS LTD III

13 2I3 PHARMS

14 2MANKIND PHARMA

15 2MENARINI INTL

16 2MICRO LABS

17 2NOVAST LABS

18 2PIRAMAL

19 2PRAXGEN

20 2RISING PHARMA

21 2SCIEGEN PHARMS INC

22 2SPIL

23 2SUN PHARM

24 2SUNSHINE

25 2TEVA PHARMS

26 2UNICHEM

27 2VKT PHARMA

filter Dosage Reset all filters

54 All

01 2GRANULES, EXTENDED RELEASE;ORAL

02 52TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

54 All

01 14DISCN

02 38RX

03 2Blank

filter Brand Name Reset all filters

54 All

01 2ASPRUZYO SPRINKLE

02 2RANEXA

03 50RANOLAZINE

filter RLD Reset all filters

54 All

01 48No

02 4Yes

03 2Blank

DRL Ranolazine Popup

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

ACTAVIS ELIZABETH

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ACTAVIS ELIZABETH

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RLD : No

TE Code : AB

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2019-05-28

Application Number : 208862

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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02

ACTAVIS ELIZABETH

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RLD : No

TE Code : AB

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM

Approval Date : 2019-05-28

Application Number : 208862

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Product Web Link

Digital Content

Corporate PDF

03

AMNEAL

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RLD : No

TE Code :

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2021-03-11

Application Number : 207690

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

AMNEAL

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AMNEAL

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RLD : No

TE Code :

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM

Approval Date : 2021-03-11

Application Number : 207690

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

CHARTWELL RX

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RLD : No

TE Code : AB

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2013-07-29

Application Number : 201046

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

CHARTWELL RX

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CHARTWELL RX

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RLD : No

TE Code : AB

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM

Approval Date : 2013-07-29

Application Number : 201046

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

TEVA PHARMS

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TEVA PHARMS

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RLD :

TE Code :

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date :

Application Number : 208174

RX/OTC/DISCN :

RLD :

TE Code :

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08

TEVA PHARMS

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TEVA PHARMS

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RLD :

TE Code :

Brand Name : RANOLAZINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1000MG

Approval Date :

Application Number : 208174

RX/OTC/DISCN :

RLD :

TE Code :

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09

MENARINI INTL

Country

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MENARINI INTL

Country

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RLD : Yes

TE Code :

Brand Name : RANEXA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2007-02-12

Application Number : 21526

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

MENARINI INTL

Country

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Country

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RLD : Yes

TE Code :

Brand Name : RANEXA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2006-01-27

Application Number : 21526

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Website

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