Periactin

NDA 13220, held by Merck. Cyproheptadine Hydrochloride.

As of Nov 13, 2026, NDA 13220 (Periactin), held by Merck, was first approved by FDA on Mar 30, 1962, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1962
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 30, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Periactin2MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Cyproheptadine Hydrochloride	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Jun 21, 1996	Supplement 41Labeling · Standard review	Approved	None posted
Oct 16, 1992	Supplement 38Manufacturing · Standard review	Approved	None posted
Aug 5, 1992	Supplement 39Labeling · Standard review	Approved	None posted
Oct 11, 1989	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 4, 1986	Supplement 36Labeling · Standard review	Approved	None posted
Nov 4, 1986	Supplement 35Manufacturing · Standard review	Approved	None posted
Nov 4, 1986	Supplement 33Labeling · Standard review	Approved	None posted
May 7, 1986	Supplement 34Labeling · Standard review	Approved	None posted
Oct 1, 1985	Supplement 32Manufacturing · Standard review	Approved	None posted
May 16, 1984	Supplement 31Labeling · Standard review	Approved	None posted
Apr 30, 1984	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 22, 1983	Supplement 29Labeling · Standard review	Approved	None posted
May 4, 1981	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 4, 1980	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 4, 1980	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 1, 1979	Supplement 25Labeling · Standard review	Approved	None posted
May 29, 1979	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 30, 1978	Supplement 23Labeling · Standard review	Approved	None posted
Mar 30, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 13220
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