Treats gingivitis as characterized. ANDA 75561, held by Bajaj. Chlorhexidine Gluconate.
As of Nov 15, 2026, ANDA 75561 (Chlorhexidine Gluconate), held by Bajaj, was first approved by FDA on Nov 14, 2000, with 5 approved supplements and 0 published complete response letters.
INDICATION: 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 |
|---|---|---|---|
| Nov 14, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chlorhexidine Gluconate0.12% · solution;dental | Chlorhexidine Gluconate | Rx |
| May 24, 2024 | Supplement 16Manufacturing | Approved | None posted |
| Nov 17, 2021 | Supplement 14Manufacturing | Approved | None posted |
| Feb 28, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 25, 2001 | Supplement 2Labeling | Approved | None posted |
| Jan 26, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Nov 14, 2000 | Original application | Approved |
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
