Orange Book product · Brand (NDA)

SODIUM NITRITE

Brand (NDA)NDA 203922RX HOPE PHARMS

Feb 14, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 14, 2012
14 yr 7 mo ago
Today
Patent 9687506 expires
Listed drug product patent expiration.
Feb 10, 2030
in 3 yr 8 mo
Patent 9687506 expires
Listed drug product patent expiration.
Feb 10, 2030
in 3 yr 8 mo
Patent 8568793 expires
Listed drug substance patent expiration.
Dec 24, 2031
in 5 yr 7 mo

Active ingredient

SODIUM NITRITE

Strength

300MG/10ML (30MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 203922

Product number

001

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
9687506	Feb 10, 2030	in 3 yr 8 mo	ProductU-3394
9687506	Feb 10, 2030	in 3 yr 8 mo	ProductU-3395
8568793	Dec 24, 2031	in 5 yr 7 mo	SubstanceProduct