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

Client Email

Product

Enzalutamide
CAS 1289942-66-0
CAS 915087-25-1
CAS 143782-23-4
CAS 749927-69-3
CAS 62-57-7
FDA Orange Book

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Midas Enzalutamide

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Enzalutamide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

48 API Suppliers, 24 USDMF, 6 EU WC, 7 KDMF, 15 NDC API, 33 Listed Suppliers, $ API Reference Price

48 API Suppliers
24 USDMF
6 EU WC
7 KDMF
15 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

50 Drugs in Development

50 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

29 API Suppliers

29 API Suppliers

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 7 FDA Orange Book, 4 Europe, 1 Canada, 3 Australia, 2 South Africa, 14 Listed Dossiers

31 FDF Dossiers
7 FDA Orange Book
4 Europe
1 Canada
3 Australia
2 South Africa
14 Listed Dossiers

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 177 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
177 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices, 16 Annual Reports

1 US Medicaid Prescriptions
3 Finished Drug Prices
16 Annual Reports

MARKET PLACE

6 APIs, 11 FDF Dossiers

6 APIs
11 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 3 US Exclusivities, 1 Health Canada Patents

26 US Patents
3 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 5,895 Xls

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filter Applicant Reset all filters

7 All

01 1ACTAVIS LABS FL INC

02 1APOTEX

03 3ASTELLAS

04 2SANDOZ INC

filter Dosage Reset all filters

7 All

01 3CAPSULE;ORAL

02 4TABLET;ORAL

filter Regulatory Info Reset all filters

7 All

01 2DISCN

02 3RX

03 2Blank

filter Brand Name Reset all filters

7 All

01 4ENZALUTAMIDE

02 3XTANDI

filter RLD Reset all filters

7 All

01 2No

02 3Yes

03 2Blank

Polpharma Enzalutamide

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
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Product Main Page

01

ACTAVIS LABS FL INC

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RLD : No

TE Code :

ENZALUTAMIDE

Brand Name : ENZALUTAMIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 40MG

Approval Date : 2021-05-14

Application Number : 209614

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

APOTEX

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APOTEX

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RLD : No

TE Code :

ENZALUTAMIDE

Brand Name : ENZALUTAMIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 40MG

Approval Date : 2022-04-22

Application Number : 209645

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Digital Content

Corporate PDF

03

ASTELLAS

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RLD : Yes

TE Code :

ENZALUTAMIDE

Brand Name : XTANDI

Dosage Form : CAPSULE;ORAL

Dosage Strength : 40MG

Approval Date : 2012-08-31

Application Number : 203415

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

ASTELLAS

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RLD : Yes

TE Code :

ENZALUTAMIDE

Brand Name : XTANDI

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Approval Date : 2020-08-04

Application Number : 213674

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ASTELLAS

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RLD : Yes

TE Code :

ENZALUTAMIDE

Brand Name : XTANDI

Dosage Form : TABLET;ORAL

Dosage Strength : 80MG

Approval Date : 2020-08-04

Application Number : 213674

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

SANDOZ INC

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SANDOZ INC

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RLD :

TE Code :

ENZALUTAMIDE

Brand Name : ENZALUTAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Approval Date :

Application Number : 216068

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

07

SANDOZ INC

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SANDOZ INC

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RLD :

TE Code :

ENZALUTAMIDE

Brand Name : ENZALUTAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 80MG

Approval Date :

Application Number : 216068

RX/OTC/DISCN :

RLD :

TE Code :

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Digital Content

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