Periactin

NDA 12649, held by Merck. Cyproheptadine Hydrochloride.

As of Nov 13, 2026, NDA 12649 (Periactin), held by Merck, was first approved by FDA on Oct 17, 1961, with 23 approved supplements and 0 published complete response letters.

First approved: Oct 17, 1961
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Oct 17, 1961	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Periactin4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cyproheptadine Hydrochloride	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Feb 25, 2000	Supplement 47Labeling · Standard review	Approved	None posted
Sep 24, 1999	Supplement 46Labeling · Standard review	Approved	Review
Jun 21, 1996	Supplement 45Labeling · Standard review	Approved	None posted
Jan 4, 1995	Supplement 43Manufacturing · Standard review	Approved	None posted
Dec 19, 1994	Supplement 42Manufacturing · Standard review	Approved	None posted
Aug 5, 1992	Supplement 41Labeling · Standard review	Approved	None posted
Jul 21, 1992	Supplement 39Manufacturing · Standard review	Approved	None posted
Oct 6, 1989	Supplement 40Manufacturing · Standard review	Approved	None posted
Nov 4, 1986	Supplement 38Labeling · Standard review	Approved	None posted
Nov 4, 1986	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 4, 1986	Supplement 34Labeling · Standard review	Approved	None posted
May 7, 1986	Supplement 36Labeling · Standard review	Approved	None posted
Oct 1, 1985	Supplement 35Manufacturing · Standard review	Approved	None posted
May 16, 1984	Supplement 33Labeling · Standard review	Approved	None posted
Apr 30, 1984	Supplement 32Manufacturing · Standard review	Approved	None posted
Apr 22, 1983	Supplement 31Labeling · Standard review	Approved	None posted
May 26, 1981	Supplement 30Manufacturing · Standard review	Approved	None posted
May 4, 1981	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 13, 1980	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 20, 1979	Supplement 27Labeling · Standard review	Approved	None posted
Mar 19, 1979	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 30, 1978	Supplement 25Labeling · Standard review	Approved	None posted
Oct 30, 1978	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 17, 1961	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12649
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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