NDA 6333, held by Cent Pharms. Theophylline Sodium Glycinate.
As of Nov 14, 2026, NDA 6333 (Synophylate), held by Cent Pharms, was first approved by FDA on Oct 17, 1947, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 1947 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| SynophylateEQ 165MG BASE/15ML ยท elixir;oral | Theophylline Sodium Glycinate | 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
