Astelin

NDA 20114, held by Rising. Azelastine Hydrochloride.

As of Nov 13, 2026, NDA 20114 (Astelin), held by Rising, was first approved by FDA on Nov 1, 1996, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1996
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Feb 17, 2006	Supplement 14Efficacy (new indication or use)	Approved	None posted
Sep 15, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter
May 30, 2000	Supplement 5Efficacy (new indication or use)	Approved	Letter
Nov 1, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Astelin0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Azelastine Hydrochloride	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Sep 6, 2018	Supplement 28Labeling · Standard review	Approved	Label
Oct 23, 2014	Supplement 26Labeling · Standard review	Approved	Label Letter
Mar 13, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 20, 2012	Supplement 23Labeling · Standard review	Approved	Label Letter
Aug 10, 2007	Supplement 17Labeling · Standard review	Approved	Letter
Feb 17, 2006	Supplement 14Efficacy (new indication or use)	Approved	None posted
Jun 27, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 13, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 15, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter
May 30, 2000	Supplement 5Efficacy (new indication or use)	Approved	Letter
Feb 16, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Sep 29, 1997	Supplement 1Labeling · Standard review	Approved	None posted
Nov 1, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20114
Drugs@FDA: Overview at FDA
Company: Rising 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