Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209379

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SELENIOUS ACID (SELENIOUS ACID)
EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)
Marketing Status: Prescription

Active Ingredient: SELENIOUS ACID
Proprietary Name: SELENIOUS ACID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209379
Product Number: 003
Approval Date: Aug 30, 2021
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SELENIOUS ACID (SELENIOUS ACID)
EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)
Marketing Status: Prescription

Active Ingredient: SELENIOUS ACID
Proprietary Name: SELENIOUS ACID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209379
Product Number: 002
Approval Date: Jan 25, 2021
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SELENIOUS ACID (SELENIOUS ACID)
EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)
Marketing Status: Prescription

Active Ingredient: SELENIOUS ACID
Proprietary Name: SELENIOUS ACID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209379
Product Number: 001
Approval Date: Apr 30, 2019
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information