Micafungin Sodium

ANDA 211713, held by Xellia Pharms Aps. Micafungin Sodium.

As of Nov 15, 2026, ANDA 211713 (Micafungin Sodium), held by Xellia Pharms Aps, was first approved by FDA on Jun 2, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 2, 2021
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
Jun 2, 2021	Original application	Approved	None posted

Products

2 strengths and forms


Micafungin SodiumEQ 50MG BASE/VIAL · injectable;intravenous	Micafungin Sodium	Rx
Micafungin SodiumEQ 100MG BASE/VIAL · injectable;intravenous	Micafungin Sodium	Rx

All 2 submissions, including labeling and manufacturing supplements


Feb 29, 2024	Supplement 2Manufacturing	Approved	None posted
Jun 2, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 211713
Drugs@FDA: Overview at FDA
Company: Xellia Pharmaceuticals ApS

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