NDA 210709, held by Noden Pharma. Aliskiren Hemifumarate.
As of Nov 13, 2026, NDA 210709 (Tekturna), held by Noden Pharma, was first approved by FDA on Nov 14, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2017 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TekturnaEQ 37.5MG BASE · capsule, pellet;oral | Aliskiren Hemifumarate | DiscontinuedReference drug |
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
