Treats gingivitis as characterized. ANDA 75006, held by Chartwell Rx. Chlorhexidine Gluconate.
As of Nov 15, 2026, ANDA 75006 (Chlorhexidine Gluconate), held by Chartwell Rx, was first approved by FDA on Mar 3, 2004, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chlorhexidine Gluconate0.12% · solution;dental | Chlorhexidine Gluconate | Rx |
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
