Desmopressin Acetate (Needs No Refrigeration)

ANDA 76703, held by Apotex. Desmopressin Acetate.

First approved: Jan 27, 2005
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 27, 2005	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Desmopressin Acetate (Needs No Refrigeration)0.01MG/SPRAY · spray, metered;nasal	Desmopressin Acetate	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 24, 2019	Supplement 27Labeling · Standard review	Approved	None posted
Oct 24, 2019	Supplement 31Labeling · Standard review	Approved	None posted
Aug 20, 2009	Supplement 17Labeling	Approved	None posted
Mar 11, 2008	Supplement 14Labeling	Approved	None posted
May 23, 2007	Supplement 10Labeling	Approved	None posted
Dec 3, 2006	Supplement 9Labeling	Approved	None posted
Mar 2, 2006	Supplement 2Labeling	Approved	None posted
Jan 27, 2005	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76703
Drugs@FDA: Overview at FDA
Company: Apotex

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