NDA 22299, held by Aurobindo Pharma Ltd. Nevirapine.
As of Nov 13, 2026, NDA 22299 (Nevirapine Tablets For Oral Suspension), held by Aurobindo Pharma Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2010 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine Tablets For Oral Suspension50MG · tablet; oral | Nevirapine | 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
