NDA 18833, held by Bayer Pharms. Lithium Carbonate.
As of Nov 13, 2026, NDA 18833 (Lithane), held by Bayer Pharms, was first approved by FDA on Jul 18, 1985, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 1985 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithane300MG · tablet;oral | Lithium Carbonate | 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
