Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021681
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.cfm

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