Treats gingivitis as characterized. ANDA 203212, held by Colgate-Palmolive Co. Chlorhexidine Gluconate.
As of Nov 15, 2026, ANDA 203212 (Periogard), held by Colgate-Palmolive Co, was first approved by FDA on Jan 28, 2016, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE PerioGard (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) 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. PerioGard 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 |
|---|---|---|---|
| Jan 28, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Periogard0.12% · solution;dental | Chlorhexidine Gluconate | Rx |
| Oct 12, 2018 | Supplement 1Manufacturing | Approved | None posted |
| Jan 28, 2016 | Original application | Approved | None posted |
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
