Floropryl

NDA 10656, held by Merck. Isoflurophate.

As of Nov 13, 2026, NDA 10656 (Floropryl), held by Merck, was first approved by FDA on Apr 2, 1957, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 2, 1957
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
Apr 2, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Floropryl0.025% · ointment;ophthalmic	Isoflurophate	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 10, 1995	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 30, 1993	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 30, 1992	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 28, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
May 4, 1990	Supplement 17Labeling · Standard review	Approved	None posted
Jan 19, 1990	Supplement 18Manufacturing · Standard review	Approved	None posted
May 30, 1989	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 4, 1987	Supplement 16Manufacturing · Standard review	Approved	None posted
May 26, 1987	Supplement 10Labeling · Standard review	Approved	None posted
Feb 12, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 6, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 27, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 19, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 9, 1978	Supplement 9Labeling · Standard review	Approved	None posted
Apr 2, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10656
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