ANDA 212917, held by Reyoung. Nebivolol Hydrochloride.
As of Nov 15, 2026, ANDA 212917 (Nebivolol Hydrochloride), held by Reyoung, was first approved by FDA on Dec 17, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2021 | Original application | Approved | None posted |
| Nebivolol HydrochlorideEQ 2.5MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
| Nebivolol HydrochlorideEQ 5MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
| Nebivolol HydrochlorideEQ 10MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
| Nebivolol HydrochlorideEQ 20MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
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
