NDA 50523, held by Parkedale. Vidarabine.
As of Nov 13, 2026, NDA 50523 (Vira-A), held by Parkedale, was first approved by FDA on Oct 18, 1978, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 1978 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vira-AEQ 187.4MG BASE/ML · injectable;injection | Vidarabine | Discontinued |
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