Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210583
Company: BAUDAX

Products on NDA 210583

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANJESO	MELOXICAM	30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2020	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210583s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210583s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210583Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2021	SUPPL-2	Labeling-Package Insert	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210583Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210583Orig1s002ltr.pdf
04/28/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210583s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210583Orig1s001ltr.pdf

Labels for NDA 210583

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210583s001lbl.pdf
02/20/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210583s000lbl.pdf