Vontrol

NDA 16033, held by Glaxosmithkline. Diphenidol Hydrochloride.

As of Nov 14, 2026, NDA 16033 (Vontrol), held by Glaxosmithkline, was first approved by FDA on Apr 5, 1967, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 5, 1967
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 5, 1967	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
VontrolEQ 25MG BASE · tablet;oral	Diphenidol Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 4Labeling	Approved	None posted
Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Mar 13, 2009	Supplement 9Labeling	Approved	None posted
Mar 13, 2009	Supplement 10Labeling	Approved	None posted
Aug 6, 2001	Supplement 11Labeling	Approved	Letter Label
Jun 6, 1986	Supplement 5Labeling	Approved	None posted
Sep 5, 1980	Supplement 6Labeling	Approved	None posted
Sep 5, 1980	Supplement 7Labeling	Approved	None posted
Apr 5, 1967	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 16033
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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