Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 217379
Company: FLEX PHARMA

Products on NDA 217379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAVHANZA	NILOTINIB	60MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	No
CAVHANZA	NILOTINIB	80MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2026	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217379Orig1s000ltr.pdf