Nocdurna

NDA 22517, held by Ferring Pharms Inc. Desmopressin Acetate.

As of Nov 14, 2026, NDA 22517 (Nocdurna), held by Ferring Pharms Inc, was first approved by FDA on Jun 21, 2018, with 0 approved supplements and 3 published complete response letters.

First approved: Jun 21, 2018
Review: Standard
Supplements approved: 0
Complete response letters: 3

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 21, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Medication Guide Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter


Jan 30, 2015	Nocdurna (desmopressin)Clinical/Statistical	Approved
Jan 30, 2013	Nocdurna (desmopressin)Clinical/Statistical, Labeling, Mary H Parks	Approved
Apr 22, 2010	Nocdurna (desmopressin)Clinical/Statistical, Clinical Pharmacology, Nonclinical	Approved

Products

2 strengths and forms


Nocdurna0.0277MG · tablet;sublingual	Desmopressin Acetate	DiscontinuedReference drug
Nocdurna0.0553MG · tablet;sublingual	Desmopressin Acetate	DiscontinuedReference drug

Identifiers

Application: NDA 22517
Drugs@FDA: Overview at FDA
Company: Ferring 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