Phospholine Iodide

NDA 11963, held by Fera Pharms LLC. Echothiophate Iodide.

As of Nov 13, 2026, NDA 11963 (Phospholine Iodide), held by Fera Pharms LLC, was first approved by FDA on Jun 27, 1960, with 25 approved supplements and 0 published complete response letters.

First approved: Jun 27, 1960
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Reduction of Elevated IOP Echothiophate iodide for ophthalmic solution is indicated for the reduction of elevated IOP. Accommodative Esotropia Concomitant esotropias with a significant accommodative component.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Jun 27, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Phospholine Iodide0.125% · for solution;ophthalmic	Echothiophate Iodide	RxReference drug
Phospholine Iodide0.03% · for solution;ophthalmic	Echothiophate Iodide	Discontinued
Phospholine Iodide0.25% · for solution;ophthalmic	Echothiophate Iodide	Discontinued
Phospholine Iodide0.06% · for solution;ophthalmic	Echothiophate Iodide	Discontinued

All 26 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 28, 2021	Supplement 52Labeling · Standard review	Approved	Letter Label
Jul 3, 2018	Supplement 48Labeling · Standard review	Approved	Letter
Feb 28, 2014	Supplement 47Manufacturing · Standard review	Approved	None posted
Mar 9, 2006	Supplement 34Labeling · Standard review	Approved	Letter Label
Apr 12, 2002	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 10, 1998	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 21, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
May 17, 1993	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 13, 1990	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 9, 1990	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 1, 1989	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 29, 1988	Supplement 25Manufacturing · Standard review	Approved	None posted
May 11, 1987	Supplement 23Labeling	Approved	None posted
Oct 30, 1984	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 10, 1982	Supplement 21Manufacturing · Standard review	Approved	None posted
May 26, 1982	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 28, 1981	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 25, 1981	Supplement 19Manufacturing · Standard review	Approved	None posted
May 19, 1981	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 2, 1980	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 1, 1979	Supplement 17Labeling	Approved	None posted
Aug 9, 1978	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 9, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 9, 1978	Supplement 15Labeling	Approved	None posted
Oct 13, 1976	Supplement 12	Approved	None posted
Jun 27, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11963
Drugs@FDA: Overview at FDA
Company: Fera Pharmaceuticals, LLC

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