Antivert

Treats vertigo associated with diseases affecting the vestibular system. NDA 10721, held by Casper Pharma LLC. Meclizine Hydrochloride.

As of Nov 15, 2026, NDA 10721 (Antivert), held by Casper Pharma LLC, was first approved by FDA on Feb 14, 1957, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 14, 1957
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jun 28, 2019	Supplement 63Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 13, 2018	Supplement 61Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 14, 1957	Original application	Approved	None posted

Products

4 strengths and forms


Antivert50MG · tablet;oral	Meclizine Hydrochloride	RxReference drug
Antivert25MG · tablet;oral	Meclizine Hydrochloride	RxReference drug
Antivert25MG · tablet, chewable;oral	Meclizine Hydrochloride	RxReference drug
Antivert12.5MG · tablet;oral	Meclizine Hydrochloride	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Jun 28, 2019	Supplement 63Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 12, 2018	Supplement 62Labeling · Standard review	Approved	Label Letter Label
Apr 13, 2018	Supplement 61Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 23, 2012	Supplement 58Labeling · Standard review	Approved	Letter Label
Dec 14, 1999	Supplement 54Manufacturing · Standard review	Approved	None posted
Nov 10, 1999	Supplement 53Manufacturing · Standard review	Approved	None posted
Sep 17, 1993	Supplement 51Manufacturing · Standard review	Approved	None posted
Sep 2, 1993	Supplement 52Manufacturing · Standard review	Approved	None posted
Mar 12, 1993	Supplement 50Manufacturing · Standard review	Approved	None posted
Feb 14, 1957	Original application	Approved	None posted

Identifiers

Application: NDA 10721
Drugs@FDA: Overview at FDA
Company: Casper Pharma

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