Viewing data from:

IVABRADINE HYDROCHLORIDE

ANDA

IVABRADINE HYDROCHLORIDE | A214051 | INGENUS PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs

10 active API suppliers hold Drug Master Files for this ingredient.

ORIL INDUSTRIEIVABRADINE HYDROCHLORIDE

DMF 279792014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDIVABRADINE HYDROCHLORIDE

DMF 286582014

ALEMBIC PHARMACEUTICALS LTDIVABRADINE HYDROCHLORIDE

DMF 320742017

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 326162019

BIONPHARMA INCIVABRADINE HYDROCHLORIDE

DMF 330772018

ZYDUS LIFESCIENCES LTDIVABRADINE HYDROCHLORIDE

DMF 331072018

URQUIMA SAIVABRADINE HYDROCHLORIDE (FORM IV)

DMF 332132018

MAITHRI LABORATORIES PRIVATE LTDIVABRADINE HYDROCHLORIDE

DMF 332462018

HETERO DRUGS LTDIVABRADINE HYDROCHLORIDE

DMF 333682018

FUXIN LONG RUI PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 333772018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 12, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 7.5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 30, 2021