Mycifradin

NDA 50285, held by Pharmacia And Upjohn. Neomycin Sulfate.

As of Nov 14, 2026, NDA 50285 (Mycifradin), held by Pharmacia And Upjohn, was first approved by FDA on Mar 13, 2009, with 33 approved supplements and 0 published complete response letters.

First approved: Mar 13, 2009
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Mar 13, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
MycifradinEQ 87.5MG BASE/5ML · solution;oral	Neomycin Sulfate	Discontinued

All 34 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 11Labeling	Approved	None posted
Mar 13, 2009	Original application	Approved	None posted
Oct 28, 1994	Supplement 34Labeling · Standard review	Approved	None posted
Feb 22, 1994	Supplement 32Manufacturing	Approved	None posted
Sep 28, 1992	Supplement 31Labeling	Approved	None posted
Jul 11, 1988	Supplement 2Labeling	Approved	None posted
Aug 23, 1984	Supplement 30Labeling	Approved	None posted
Aug 23, 1984	Supplement 29Labeling	Approved	None posted
Jan 20, 1983	Supplement 1Manufacturing	Approved	None posted
Feb 5, 1982	Supplement 28Manufacturing	Approved	None posted
Apr 1, 1981	Supplement 27Manufacturing	Approved	None posted
Apr 18, 1979	Supplement 26Labeling	Approved	None posted
Feb 27, 1979	Supplement 25Manufacturing	Approved	None posted
May 18, 1978	Supplement 24Manufacturing	Approved	None posted
Jan 26, 1978	Supplement 23Manufacturing	Approved	None posted
May 10, 1976	Supplement 22Manufacturing	Approved	None posted
Dec 8, 1975	Supplement 21Labeling	Approved	None posted
Jul 1, 1975	Supplement 20Manufacturing	Approved	None posted
Jan 23, 1975	Supplement 19Manufacturing	Approved	None posted
Jan 20, 1975	Supplement 18Labeling	Approved	None posted
Nov 11, 1974	Supplement 17Manufacturing	Approved	None posted
May 28, 1974	Supplement 16Labeling	Approved	None posted
May 1, 1974	Supplement 15Manufacturing	Approved	None posted
Feb 25, 1974	Supplement 14Manufacturing	Approved	None posted
Feb 26, 1973	Supplement 13Manufacturing	Approved	None posted
Jun 19, 1972	Supplement 12Labeling	Approved	None posted
Apr 26, 1972	Supplement 10Labeling	Approved	None posted
Apr 19, 1972	Supplement 9Manufacturing	Approved	None posted
Apr 10, 1972	Supplement 8Manufacturing	Approved	None posted
Nov 1, 1971	Supplement 7Labeling	Approved	None posted
Apr 26, 1971	Supplement 6Manufacturing	Approved	None posted
Mar 18, 1971	Supplement 5Manufacturing	Approved	None posted
Feb 25, 1971	Supplement 4Labeling	Approved	None posted
Feb 23, 1971	Supplement 3Labeling	Approved	None posted

Identifiers

Application: NDA 50285
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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