Selenious Acid
These highlights do not include all the information needed to use SELENIOUS ACID INJECTION safely and effectively. See full prescribing information for SELENIOUS ACID INJECTION. SELENIOUS ACID INJECTION, for intravenous use Initial U.S. Approval: 2019
Approved
Approval ID
49324999-50e3-43ed-a8dd-156d6dbedd9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2021
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Selenious Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-6502
Application NumberNDA209379
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selenious Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2021
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SELENIUMActive
Quantity: 6 ug in 1 mL
Code: H6241UJ22B
Classification: ACTIB
NITRIC ACIDInactive
Code: 411VRN1TV4
Classification: IACT
Selenious Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-6560
Application NumberNDA209379
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selenious Acid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2021
FDA Product Classification
INGREDIENTS (3)
NITRIC ACIDInactive
Code: 411VRN1TV4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SELENIUMActive
Quantity: 60 ug in 1 mL
Code: H6241UJ22B
Classification: ACTIB