Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021681
Company: MISSION PHARMA
Company: MISSION PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TINDAMAX | TINIDAZOLE | 250MG | TABLET; ORAL | Prescription | None | No | No |
| TINDAMAX | TINIDAZOLE | 500MG | TABLET; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/17/2004 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD; Orphan |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.html |