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01 2ALKEM LABS LTD

02 3APGDI

03 2APOTEX

04 1AUROBINDO PHARMA LTD

05 2LUPIN LTD

06 2QILU PHARMACEUTICAL CO., LTD.

07 2SAWAI USA

08 2ZYDUS PHARMS

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PharmaCompass

01

APGDI

U.S.A
HPAPI Summit
Not Confirmed
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APGDI

U.S.A
arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

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02

APGDI

U.S.A
HPAPI Summit
Not Confirmed
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APGDI

U.S.A
arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

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03

HPAPI Summit
Not Confirmed
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HPAPI Summit
Not Confirmed

MIRABEGRON

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

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04

HPAPI Summit
Not Confirmed
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HPAPI Summit
Not Confirmed

MIRABEGRON

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

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05

HPAPI Summit
Not Confirmed
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arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

HPAPI Summit
Not Confirmed
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arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

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07

HPAPI Summit
Not Confirmed
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arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

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08

HPAPI Summit
Not Confirmed
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arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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 :

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09

HPAPI Summit
Not Confirmed
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arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

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10

HPAPI Summit
Not Confirmed
arrow
arrow
HPAPI Summit
Not Confirmed

MIRABEGRON

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

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