Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 218328
Company: SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD

Products on NDA 218328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEHIPPY	VORTIOXETINE	5MG	TABLET; ORALLY DISINTEGRATING	None (Tentative Approval)	None	No	No
SEHIPPY	VORTIOXETINE	10MG	TABLET; ORALLY DISINTEGRATING	None (Tentative Approval)	None	No	No
SEHIPPY	VORTIOXETINE	20MG	TABLET; ORALLY DISINTEGRATING	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2024	ORIG-1	Tentative Approval	Type 2 - New Active Ingredient and Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218328Orig1s000TAltr.pdf