ANDA 220376, held by Zenara Pharma Private Ltd. Viloxazine Hydrochloride.
As of Nov 15, 2026, ANDA 220376 (Viloxazine Hydrochloride), held by Zenara Pharma Private Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2026 | Original application | Tentative approval | None posted |
| Viloxazine Hydrochloride200MG · capsule, extended release | Viloxazine Hydrochloride | None (tentative approval) |
| Viloxazine Hydrochloride150MG · capsule, extended release | Viloxazine Hydrochloride | None (tentative approval) |
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
