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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219633
Company: ASPIRO

Products on ANDA 219633

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELENIOUS ACID	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/11/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219633

SELENIOUS ACID

SOLUTION;INTRAVENOUS; EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELENIOUS ACID	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209379	AM REGENT
SELENIOUS ACID	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219633	ASPIRO
SELENIOUS ACID	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218661	CIPLA

SOLUTION;INTRAVENOUS; EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209379	AM REGENT
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219633	ASPIRO
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218661	CIPLA
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219629	GLAND
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219472	KINDOS
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218536	RK PHARMA
SELENIOUS ACID	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219547	SUN PHARM

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