Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216068
Company: SANDOZ

Products on ANDA 216068

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENZALUTAMIDE	ENZALUTAMIDE	40MG	TABLET;ORAL	Prescription	AB	No	No
ENZALUTAMIDE	ENZALUTAMIDE	80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216068Orig1s000Panoramaltr.pdf

Therapeutic Equivalents for ANDA 216068

ENZALUTAMIDE

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENZALUTAMIDE	ENZALUTAMIDE	40MG	TABLET;ORAL	Prescription	No	AB	216068	SANDOZ
XTANDI	ENZALUTAMIDE	40MG	TABLET;ORAL	Prescription	Yes	AB	213674	ASTELLAS

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENZALUTAMIDE	ENZALUTAMIDE	80MG	TABLET;ORAL	Prescription	No	AB	216068	SANDOZ
XTANDI	ENZALUTAMIDE	80MG	TABLET;ORAL	Prescription	Yes	AB	213674	ASTELLAS