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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021618
Company: MISSION PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TINDAMAX TINIDAZOLE 250MG TABLET;ORAL Prescription AB Yes No
TINDAMAX TINIDAZOLE 500MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021618s008lbl.pdf
10/09/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21618s007lbl.pdf
06/07/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021618s006lbl.pdf
05/21/2007 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021618s003lbl.pdf
05/17/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21618_tindamax_lbl.pdf
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