Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218596
Company: ZYDUS

Products on ANDA 218596

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIROXIMEL FUMARATE	DIROXIMEL FUMARATE	231MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218596

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218596Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 218596

DIROXIMEL FUMARATE

CAPSULE, DELAYED RELEASE;ORAL; 231MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIROXIMEL FUMARATE	DIROXIMEL FUMARATE	231MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	218596	ZYDUS
VUMERITY	DIROXIMEL FUMARATE	231MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	211855	BIOGEN INC