Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 216469
Company: COLUMBIA THERAPEUTICS INC

Products on NDA 216469

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYINFLA	COLCHICINE	0.5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216469

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2025	ORIG-1	Tentative Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216469Orig1s000TAltr.pdf