Treats trichomoniasis caused by Trichomonas vaginalis. NDA 21618, held by Mission Pharma. Tinidazole.
As of Nov 14, 2026, NDA 21618 (Tindamax), held by Mission Pharma, was first approved by FDA on May 17, 2004, with 5 approved supplements and 0 published complete response letters.
1 INDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age. 1.
| May 21, 2007 | Supplement 3Efficacy (new indication or use) | Approved | |
| May 17, 2004 | Original applicationNew molecular entity · Standard review | Approved |
| Tindamax250MG · tablet;oral | Tinidazole | RxReference drug |
| Tindamax500MG · tablet;oral | Tinidazole | RxReference drug |
| Dec 15, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Oct 9, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Jun 7, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Apr 1, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 21, 2007 | Supplement 3Efficacy (new indication or use) | Approved | |
| May 17, 2004 | Original applicationNew molecular entity · Standard review | 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
