Amphotec

NDA 50729, held by Alkopharma USA. Amphotericin B.

As of Nov 13, 2026, NDA 50729 (Amphotec), held by Alkopharma USA, was first approved by FDA on Nov 22, 1996, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 22, 1996
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 22, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Amphotec50MG/VIAL · injectable, lipid complex;injection	Amphotericin B	Discontinued
Amphotec100MG/VIAL · injectable, lipid complex;injection	Amphotericin B	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 27, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Nov 22, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50729
Drugs@FDA: Overview at FDA
Company: Alkopharma USA

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