Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214935
Company: OPTIMUS PHARMA PRIVATE LTD

Products on ANDA 214935

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OBETICHOLIC ACID	OBETICHOLIC ACID	5mg	TABLET; ORAL	None (Tentative Approval)	None	No	No
OBETICHOLIC ACID	OBETICHOLIC ACID	10mg	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214935

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2023	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.