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

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01 2ALEMBIC PHARMS LTD

02 3AMGEN INC

03 2ANNORA PHARMA

04 2BIONPHARMA

05 2INGENUS PHARMS LLC

06 2ZYDUS PHARMS

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2021-12-30

Application Number : 214051

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : CORLANOR

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2015-04-15

Application Number : 206143

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : CORLANOR

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2015-04-15

Application Number : 206143

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE

Brand Name : CORLANOR

Dosage Form : SOLUTION;ORAL

Dosage Strength : 5MG/5ML (1MG/ML)

Approval Date : 2019-04-22

Application Number : 209964

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2022-10-05

Application Number : 213366

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2022-10-05

Application Number : 213366

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2024-09-05

Application Number : 213276

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2024-09-05

Application Number : 213276

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2023-11-29

Application Number : 213442

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

IVABRADINE HYDROCHLORIDE

Brand Name : IVABRADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 7.5MG BASE

Approval Date : 2023-11-29

Application Number : 213442

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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