Question 1

Is there a generic for Sodium nitrite?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Sodium nitrite. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Sodium nitrite?

Accepted Answer

SODIUM NITRITE (NDA 203922, HOPE PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sodium nitrite?

Accepted Answer

The Orange Book lists 2 patents against Sodium nitrite products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Sodium nitrite are approved?

Accepted Answer

Sodium nitrite is approved in the following dosage form: solution.

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

Sodium nitrite

Brand (NDA) products · solution

Listed patents (2)

Sodium nitrite — frequently asked questions

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