Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220051
Company: BPI LABS LLC

Products on ANDA 220051

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELENIOUS ACID	SELENIOUS ACID	600UG/10ML	INJECTION	None (Tentative Approval)	None	No	No
SELENIOUS ACID	SELENIOUS ACID	12UG/2ML	INJECTION	None (Tentative Approval)	None	No	No
SELENIOUS ACID	SELENIOUS ACID	60UG/1ML	INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220051

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.