Poly-Pred

NDA 50081, held by Allergan. Neomycin Sulfate; Polymyxin B Sulfate; Prednisolone Acetate.

As of Nov 14, 2026, NDA 50081 (Poly-Pred), held by Allergan, was first approved by FDA on May 10, 1963, with 23 approved supplements and 0 published complete response letters.

First approved: May 10, 1963
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
May 10, 1963	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Poly-PredEQ 0.35% BASE;10,000 UNITS/ML;0.5% · suspension/drops;ophthalmic	Neomycin Sulfate; Polymyxin B Sulfate; Prednisolone Acetate	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Mar 19, 2003	Supplement 38Labeling · Standard review	Approved	None posted
Apr 12, 2002	Supplement 36Manufacturing	Approved	None posted
Feb 21, 2002	Supplement 35Manufacturing	Approved	None posted
Apr 12, 2001	Supplement 32Manufacturing	Approved	None posted
Oct 2, 2000	Supplement 31Manufacturing	Approved	None posted
May 19, 1998	Supplement 30Manufacturing	Approved	None posted
Aug 3, 1995	Supplement 15Manufacturing	Approved	None posted
Mar 7, 1994	Supplement 13Manufacturing	Approved	None posted
Aug 17, 1987	Supplement 11Manufacturing	Approved	None posted
Dec 12, 1985	Supplement 9Manufacturing	Approved	None posted
Nov 1, 1985	Supplement 5Manufacturing	Approved	None posted
Sep 4, 1985	Supplement 8Manufacturing	Approved	None posted
May 15, 1984	Supplement 3Labeling	Approved	None posted
Feb 10, 1984	Supplement 6Manufacturing	Approved	None posted
Oct 18, 1983	Supplement 4Manufacturing	Approved	None posted
Oct 26, 1982	Supplement 1Manufacturing	Approved	None posted
Aug 2, 1982	Supplement 29Manufacturing	Approved	None posted
Jun 30, 1981	Supplement 28Manufacturing	Approved	None posted
Mar 18, 1980	Supplement 25Manufacturing	Approved	None posted
Nov 16, 1979	Supplement 24Labeling	Approved	None posted
Dec 2, 1965	Supplement 18Labeling	Approved	None posted
Jun 23, 1964	Supplement 10Manufacturing	Approved	None posted
Oct 23, 1963	Supplement 7Labeling	Approved	None posted
May 10, 1963	Original application	Approved	None posted

Identifiers

Application: NDA 50081
Drugs@FDA: Overview at FDA
Company: Allergan

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