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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211210
Company: TERSERA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QMIIZ ODT MELOXICAM 7.5MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
QMIIZ ODT MELOXICAM 15MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes 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
10/19/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211210s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211210Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211210Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211210s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211210Orig1s002ltr.pdf
08/20/2019 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211210Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2021 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211210s002lbl.pdf
04/28/2021 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211210s002lbl.pdf
10/19/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211210s000lbl.pdf
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