Mirabegron [USAN:INN] | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Mirabegron [USAN:INN]
FDA Orange Book

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Mirabegron [USAN:INN]

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

109 API Suppliers, 32 USDMF, 8 CEP/COS, 20 EU WC, 33 KDMF, 25 NDC API, 66 Listed Suppliers, $ API Reference Price

109 API Suppliers
32 USDMF
8 CEP/COS
20 EU WC
33 KDMF
25 NDC API
66 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

68 Intermediate Suppliers

68 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 17 FDA Orange Book, 15 Europe, 2 Canada, 4 South Africa, 9 Listed Dossiers

47 FDF Dossiers
17 FDA Orange Book
15 Europe
2 Canada
4 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

29 News #PharmaBuzz

29 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 15 Regulatory FDF Prices, 9 Annual Reports

1 US Medicaid Prescriptions
15 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

18 APIs, 3 FDF Dossiers

18 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

28 US Patents, 8 Health Canada Patents

28 US Patents
8 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 12 Others

2 USP
12 Others

$ API Ref.Price (USD/KG) : 1,465 Xls

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filter Applicant Reset all filters

17 All

01 2ALKEM LABS LTD

02 3APGDI

03 2APOTEX

04 1ASCENT PHARMS INC

05 1AUROBINDO PHARMA LTD

06 2LUPIN LTD

07 2QILU PHARMACEUTICAL CO., LTD.

08 2SAWAI USA

09 2ZYDUS PHARMS

filter Dosage Reset all filters

17 All

01 1FOR SUSPENSION, EXTENDED RELEASE;ORAL

02 3TABLET, EXTENDED RELEASE

03 13TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

17 All

01 3DISCN

02 10RX

03 4Blank

filter Brand Name Reset all filters

17 All

01 14MIRABEGRON

02 2MYRBETRIQ

03 1MYRBETRIQ GRANULES

filter RLD Reset all filters

17 All

01 10No

02 3Yes

03 4Blank

Synnat Mirabegron

List of Suppliers

Product Main Page

01

APGDI

U.S.A

APGA Annual Conference

Not Confirmed

APGDI

U.S.A

APGA Annual Conference

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

APGA Annual Conference

Not Confirmed

APGDI

U.S.A

APGA Annual Conference

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

APGA Annual Conference

Not Confirmed

APOTEX

APGA Annual Conference

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2025-01-02

Application Number : 209434

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

APOTEX

APGA Annual Conference

Not Confirmed

APOTEX

APGA Annual Conference

Not Confirmed

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Digital Content

RLD : No

TE Code :

Brand Name : MIRABEGRON

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date : 2025-01-02

Application Number : 209434

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AUROBINDO PHARMA LTD

APGA Annual Conference

Not Confirmed

AUROBINDO PHARMA LTD

APGA Annual Conference

Not Confirmed

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Digital Content

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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

LUPIN LTD

APGA Annual Conference

Not Confirmed

LUPIN LTD

APGA Annual Conference

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 : 2022-09-28

Application Number : 209485

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

LUPIN LTD

APGA Annual Conference

Not Confirmed

LUPIN LTD

APGA Annual Conference

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SAWAI USA

APGA Annual Conference

Not Confirmed

SAWAI USA

APGA Annual Conference

Not Confirmed

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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

Corporate PDF

09

ZYDUS PHARMS

APGA Annual Conference

Not Confirmed

ZYDUS PHARMS

APGA Annual Conference

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

APGA Annual Conference

Not Confirmed

ZYDUS PHARMS

APGA Annual Conference

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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