Placidyl

NDA 10021, held by Abbvie. Ethchlorvynol.

As of Nov 13, 2026, NDA 10021 (Placidyl), held by Abbvie, was first approved by FDA on May 10, 1961, with 14 approved supplements and 0 published complete response letters.

First approved: May 10, 1961
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 10, 1961	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Placidyl500MG · capsule;oral	Ethchlorvynol	Discontinued
Placidyl100MG · capsule;oral	Ethchlorvynol	Discontinued
Placidyl200MG · capsule;oral	Ethchlorvynol	Discontinued
Placidyl750MG · capsule;oral	Ethchlorvynol	Discontinued

All 15 submissions, including labeling and manufacturing supplements


May 8, 1998	Supplement 44Manufacturing · Standard review	Approved	None posted
Oct 19, 1995	Supplement 43Manufacturing · Standard review	Approved	None posted
May 4, 1989	Supplement 42Manufacturing · Standard review	Approved	None posted
Dec 3, 1987	Supplement 41Manufacturing · Standard review	Approved	None posted
Dec 5, 1986	Supplement 40Manufacturing · Standard review	Approved	None posted
Mar 12, 1986	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 8, 1983	Supplement 36Labeling · Standard review	Approved	None posted
Oct 1, 1982	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 22, 1982	Supplement 38Labeling · Standard review	Approved	None posted
Nov 19, 1981	Supplement 37Manufacturing · Standard review	Approved	None posted
Mar 6, 1981	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 7, 1979	Supplement 33Labeling · Standard review	Approved	None posted
May 7, 1976	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 10, 1976	Supplement 28Manufacturing · Standard review	Approved	None posted
May 10, 1961	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 10021
Drugs@FDA: Overview at FDA
Company: AbbVie

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