NDA 21681, held by Mission Pharma. Tinidazole.
As of Nov 15, 2026, NDA 21681 (Tindamax), held by Mission Pharma, was first approved by FDA on May 17, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 17, 2004 | Original applicationTYPE 6 · Standard review | Approved |
| Tindamax250MG · tablet; oral | Tinidazole | Rx |
| Tindamax500MG · tablet; oral | Tinidazole | 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
