NDA 209964, held by Amgen Inc. Ivabradine.
As of Nov 13, 2026, NDA 209964 (Corlanor), held by Amgen Inc, was first approved by FDA on Apr 22, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2019 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Corlanor5MG/5ML (1MG/ML) · solution;oral | Ivabradine | DiscontinuedReference drug |
| Aug 4, 2021 | Supplement 2Labeling · Standard review | Approved | |
| Apr 22, 2019 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
