Pred-G

NDA 50612, held by Allergan. Gentamicin Sulfate; Prednisolone Acetate.

As of Nov 13, 2026, NDA 50612 (Pred-G), held by Allergan, was first approved by FDA on Dec 1, 1989, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 1, 1989
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 1, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pred-GEQ 0.3% BASE;0.6% · ointment;ophthalmic	Gentamicin Sulfate; Prednisolone Acetate	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Jun 7, 2018	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 20, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Oct 22, 2003	Supplement 14Manufacturing · Standard review	Approved	Letter
Jan 28, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 9, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 16, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 26, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 29, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 4, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 1, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50612
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