NDA 22420, held by Strides Arcolab Ltd. Efavirenz.
As of Nov 15, 2026, NDA 22420 (Efavirenz 200mg Scored Tablets), held by Strides Arcolab Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2010 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efavirenz 200mg Scored Tablets200MG · tablet; oral | Efavirenz | 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
