Nithiodote

Treats acute cyanide poisoning. NDA 201444, held by Hope Pharms. Sodium Nitrite; Sodium Thiosulfate.

As of Nov 13, 2026, NDA 201444 (Nithiodote), held by Hope Pharms, was first approved by FDA on Jan 14, 2011, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2011
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jan 14, 2011	Original applicationNew formulation or manufacturer · Priority review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nithiodote300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) · solution, solution;intravenous, intravenous	Sodium Nitrite; Sodium Thiosulfate	RxReference drug

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 13, 2021	Supplement 26Labeling · Standard review	Approved	Letter Label
Oct 19, 2017	Supplement 19Labeling · Standard review	Approved	Label Letter
Jun 14, 2016	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 22, 2016	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 3, 2015	Supplement 16Manufacturing · Priority review	Approved	None posted
Jan 26, 2015	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 24, 2014	Supplement 13Manufacturing · Priority review	Approved	None posted
Jun 3, 2014	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 14, 2013	Supplement 11Manufacturing · Priority review	Approved	None posted
Apr 8, 2013	Supplement 10Manufacturing · Priority review	Approved	None posted
Mar 28, 2013	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 14, 2011	Original applicationNew formulation or manufacturer · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 201444
Drugs@FDA: Overview at FDA
Company: Hope Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters