Neo-Rx

ANDA 61579, held by X Gen Pharms. Neomycin Sulfate.

As of Nov 15, 2026, ANDA 61579 (Neo-Rx), held by X Gen Pharms, was first approved by FDA on Jan 5, 1972, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 5, 1972
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 5, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neo-Rx100% · powder;for rx compounding	Neomycin Sulfate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 27, 2001	Supplement 4Manufacturing	Approved	None posted
Nov 15, 1999	Supplement 3Manufacturing	Approved	None posted
Jul 29, 1994	Supplement 1Manufacturing	Approved	None posted
Jun 20, 1994	Supplement 2Manufacturing	Approved	None posted
Jan 5, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 61579
Drugs@FDA: Overview at FDA
Company: X-Gen 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