Micafungin

NDA 212156, held by Ph Health. Micafungin Sodium.

As of Nov 13, 2026, NDA 212156 (Micafungin), held by Ph Health, was first approved by FDA on Jun 16, 2021, with 0 approved supplements and 1 published complete response letter.

First approved: Jun 16, 2021
Review: Standard
Supplements approved: 0
Complete response letters: 1

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 16, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
May 18, 2020	MicafunginProduct Quality, Nonclinical, Facility Inspections	Approved

Products

2 strengths and forms


MicafunginEQ 50MG BASE/VIAL · powder;intravenous	Micafungin Sodium	DiscontinuedReference drug
MicafunginEQ 100MG BASE/VIAL · powder;intravenous	Micafungin Sodium	DiscontinuedReference drug

Identifiers

Application: NDA 212156
Drugs@FDA: Overview at FDA
Company: PH Health

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