Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211210
Company: TERSERA

• Medication Guide

Products on NDA 211210

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QMIIZ ODT	MELOXICAM	7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
QMIIZ ODT	MELOXICAM	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211210

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert	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

Labels for NDA 211210

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