← FDA DRUG APPROVALS

FDA NDA · NDA209964

CORLANOR

ivabradine

Sponsor: AMGEN INC

APPLICATION
NDA209964
TYPE
NDA
ORIGINAL APPROVAL
2019-04-22
LATEST ACTION
2021-08-04
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CORLANOR · ReferenceDiscontinued
IVABRADINE 5MG/5ML (1MG/ML) · SOLUTION · ORAL

Approval history

2021-08-04Labeling · Supplement 2 · standard — Label ↗AP
2019-04-22Type 3 - New Dosage Form · Original · priority — Label ↗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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