Minirin

NDA 21333, held by Ferring. Desmopressin Acetate.

As of Nov 14, 2026, NDA 21333 (Minirin), held by Ferring, was first approved by FDA on Sep 16, 2002, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2002
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 16, 2002	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Minirin0.01MG/SPRAY · spray, metered;nasal	Desmopressin Acetate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


May 29, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 8, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
Sep 4, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 11, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 4, 2003	Supplement 1Labeling · Standard review	Approved	Letter Label
Sep 16, 2002	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21333
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