Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216616
Company: EVITA SOLUTIONS

Products on ANDA 216616

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIFEPRISTONE	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216616

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf

Therapeutic Equivalents for ANDA 216616

MIFEPRISTONE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIFEPREX	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	Yes	AB	020687	DANCO LABS LLC
MIFEPRISTONE	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	No	AB	216616	EVITA SOLUTIONS
MIFEPRISTONE	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	No	AB	091178	GENBIOPRO