Desmopressin Acetate

NDA 21795, held by Ferring. Desmopressin Acetate.

As of Nov 14, 2026, NDA 21795 (Desmopressin Acetate), held by Ferring, was first approved by FDA on May 8, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: May 8, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 8, 2008	Original applicationNew formulation or manufacturer	Approved	Summary Review Review Letter Pediatric Medical Review

Products

2 strengths and forms


Desmopressin Acetate0.1MG · tablet;oral	Desmopressin Acetate	Discontinued
Desmopressin Acetate0.2MG · tablet;oral	Desmopressin Acetate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Oct 29, 2019	Supplement 6Labeling · Standard review	Approved	Label Letter
Apr 20, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 28, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
May 8, 2008	Original applicationNew formulation or manufacturer	Approved	Summary Review Review Letter Pediatric Medical Review

Identifiers

Application: NDA 21795
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