Orange Book product · Brand (NDA)

SELENIOUS ACID

Brand (NDA)NDA 209379TE APRX AM REGENT

Aug 30, 2021

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 30, 2021
4 yr 10 mo ago
Today
Patent 11998565 expires
Listed drug product patent expiration.
Jul 01, 2041
in 15 yr 3 mo
Patent 12150957 expires
Listed method-of-use patent (U-4039) expiration.
Jul 01, 2041
in 15 yr 3 mo

Active ingredient

SELENIOUS ACID

Strength

EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 209379

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11998565	Jul 01, 2041	in 15 yr 3 mo	Product
12150957	Jul 01, 2041	in 15 yr 3 mo	U-4039