Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217585
Company: MSN

Products on ANDA 217585

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLUMIANT	BARICITINIB	1MG	TABLET;ORAL	Prescription	AB	No	No
OLUMIANT	BARICITINIB	2MG	TABLET;ORAL	Prescription	AB	No	No
OLUMIANT	BARICITINIB	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217585

OLUMIANT

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLUMIANT	BARICITINIB	1MG	TABLET;ORAL	Prescription	Yes	AB	207924	ELI LILLY AND CO
OLUMIANT	BARICITINIB	1MG	TABLET;ORAL	Prescription	No	AB	217585	MSN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLUMIANT	BARICITINIB	2MG	TABLET;ORAL	Prescription	Yes	AB	207924	ELI LILLY AND CO
OLUMIANT	BARICITINIB	2MG	TABLET;ORAL	Prescription	No	AB	217585	MSN

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLUMIANT	BARICITINIB	4MG	TABLET;ORAL	Prescription	Yes	AB	207924	ELI LILLY AND CO
OLUMIANT	BARICITINIB	4MG	TABLET;ORAL	Prescription	No	AB	217585	MSN