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FDA ANDA · ANDA214051

IVABRADINE

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA214051
TYPE
ANDA
ORIGINAL APPROVAL
2021-12-30
LATEST ACTION
2021-12-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

IVABRADINE HYDROCHLORIDEPrescription
IVABRADINE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
IVABRADINE HYDROCHLORIDEPrescription
IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE · TABLET · ORAL

Approval history

2021-12-30UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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