Kemadrin

NDA 9818, held by Monarch Pharms. Procyclidine Hydrochloride.

As of Nov 13, 2026, NDA 9818 (Kemadrin), held by Monarch Pharms, was first approved by FDA on Jul 27, 1955, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 27, 1955
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 27, 1955	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Kemadrin5MG · tablet;oral	Procyclidine Hydrochloride	Discontinued
Kemadrin2MG · tablet;oral	Procyclidine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jul 1, 2011	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 3, 1982	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 19, 1980	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 14, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 10, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 10, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 9, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 27, 1976	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 25, 1974	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 27, 1955	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 9818
Drugs@FDA: Overview at FDA
Company: Monarch Pharmaceuticals

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