NDA 7794, held by Teva. Dyphylline.
As of Nov 13, 2026, NDA 7794 (Neothylline), held by Teva, was first approved by FDA on Mar 7, 1951, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 1951 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Neothylline200MG · tablet;oral | Dyphylline | Discontinued |
| Neothylline400MG · tablet;oral | Dyphylline | Discontinued |
| Neothylline160MG/15ML · elixir;oral | Dyphylline | 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
