(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide
FDA Orange Book

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(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide

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ACTIVE PHARMA INGREDIENTS

75 API Suppliers, 32 USDMF, 2 CEP/COS, 13 EU WC, 30 KDMF, 25 NDC API, 60 Listed Suppliers, $ API Reference Price

75 API Suppliers
32 USDMF
2 CEP/COS
13 EU WC
30 KDMF
25 NDC API
60 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

58 Intermediate Suppliers

58 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

43 FDF Dossiers, 15 FDA Orange Book, 15 Europe, 2 Canada, 2 South Africa, 9 Listed Dossiers

43 FDF Dossiers
15 FDA Orange Book
15 Europe
2 Canada
2 South Africa
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 25MG, TABLET, EXTENDED RELEASE;ORAL - 50MG

TABLET, EXTENDED RELEASE;ORAL - 25MG
TABLET, EXTENDED RELEASE;ORAL - 50MG

DIGITAL CONTENT

28 News #PharmaBuzz

28 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 15 Regulatory FDF Prices, 8 Annual Reports

1 US Medicaid Prescriptions
15 Regulatory FDF Prices
8 Annual Reports

MARKET PLACE

17 APIs, 3 FDF Dossiers

17 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

24 US Patents, 8 Health Canada Patents

24 US Patents
8 Health Canada Patents

REF. STANDARDS & IMPURITIES

20 Others

20 Others

$ API Ref.Price (USD/KG) : 1,531 Xls

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15 All

01 2ALKEM LABS LTD

02 3APGDI

03 2APOTEX

04 1AUROBINDO PHARMA LTD

05 2LUPIN LTD

06 2QILU PHARMACEUTICAL CO., LTD.

07 1SAWAI USA

08 2ZYDUS PHARMS

filter Dosage Reset all filters

15 All

01 1FOR SUSPENSION, EXTENDED RELEASE;ORAL

02 2TABLET, EXTENDED RELEASE

03 12TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

15 All

01 1DISCN

02 11RX

03 3Blank

filter Brand Name Reset all filters

15 All

01 12MIRABEGRON

02 2MYRBETRIQ

03 1MYRBETRIQ GRANULES

filter RLD Reset all filters

15 All

01 9No

02 3Yes

03 3Blank

Synnat Mirabegron

List of Suppliers

Product Main Page

01

APGDI

U.S.A

Bio-Europe Spring

Not Confirmed

APGDI

U.S.A

Bio-Europe Spring

Not Confirmed

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U.S.A

Digital Content

RLD : Yes

TE Code : AB

Brand Name : MYRBETRIQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2012-06-28

Application Number : 202611

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

02

APGDI

U.S.A

Bio-Europe Spring

Not Confirmed

APGDI

U.S.A

Bio-Europe Spring

Not Confirmed

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U.S.A

Digital Content

RLD : Yes

TE Code : AB

Brand Name : MYRBETRIQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date : 2012-06-28

Application Number : 202611

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

03

APOTEX

Bio-Europe Spring

Not Confirmed

APOTEX

Bio-Europe Spring

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2025-01-02

Application Number : 209434

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

APOTEX

Bio-Europe Spring

Not Confirmed

APOTEX

Bio-Europe Spring

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date : 2025-01-02

Application Number : 209434

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AUROBINDO PHARMA LTD

Bio-Europe Spring

Not Confirmed

AUROBINDO PHARMA LTD

Bio-Europe Spring

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RLD :

TE Code :

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 209413

RX/OTC/DISCN :

RLD :

TE Code :

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06

LUPIN LTD

Bio-Europe Spring

Not Confirmed

LUPIN LTD

Bio-Europe Spring

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RLD : No

TE Code : AB

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2022-09-28

Application Number : 209485

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

07

LUPIN LTD

Bio-Europe Spring

Not Confirmed

LUPIN LTD

Bio-Europe Spring

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 : No

TE Code : AB

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date : 2022-09-28

Application Number : 209485

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

08

SAWAI USA

Bio-Europe Spring

Not Confirmed

SAWAI USA

Bio-Europe Spring

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 : No

TE Code :

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2019-12-27

Application Number : 209446

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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09

ZYDUS PHARMS

Bio-Europe Spring

Not Confirmed

ZYDUS PHARMS

Bio-Europe Spring

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 : No

TE Code : AB

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2022-09-29

Application Number : 209488

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

ZYDUS PHARMS

Bio-Europe Spring

Not Confirmed

ZYDUS PHARMS

Bio-Europe Spring

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.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : No

TE Code : AB

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date : 2022-09-29

Application Number : 209488

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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