Fungizone

NDA 50314, held by Apothecon. Amphotericin B.

As of Nov 14, 2026, NDA 50314 (Fungizone), held by Apothecon, was first approved by FDA on Feb 7, 1966, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 7, 1966
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 7, 1966	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fungizone3% · cream;topical	Amphotericin B	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jun 13, 1996	Supplement 29Manufacturing	Approved	None posted
May 7, 1993	Supplement 6Manufacturing	Approved	None posted
Aug 24, 1978	Supplement 17Manufacturing	Approved	None posted
Jun 12, 1978	Supplement 15Manufacturing	Approved	None posted
Nov 28, 1975	Supplement 14Manufacturing	Approved	None posted
Jan 12, 1971	Supplement 7Labeling	Approved	None posted
Feb 7, 1966	Original application	Approved	None posted

Identifiers

Application: NDA 50314
Drugs@FDA: Overview at FDA
Company: Apothecon

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