Caspofungin Acetate

ANDA 211263, held by Areva Pharms. Caspofungin Acetate.

As of Nov 15, 2026, ANDA 211263 (Caspofungin Acetate), held by Areva Pharms, was first approved by FDA on Oct 1, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 1, 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
Oct 1, 2021	Original application	Approved	None posted

Products

2 strengths and forms


Caspofungin Acetate50MG/VIAL · powder;intravenous	Caspofungin Acetate	Rx
Caspofungin Acetate70MG/VIAL · powder;intravenous	Caspofungin Acetate	Rx

All 2 submissions, including labeling and manufacturing supplements


Dec 10, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Oct 1, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 211263
Drugs@FDA: Overview at FDA
Company: Areva Pharmaceuticals

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