Caspofungin Acetate

ANDA 209489, held by Cipla. Caspofungin Acetate.

As of Nov 15, 2026, ANDA 209489 (Caspofungin Acetate), held by Cipla, was first approved by FDA on Jul 12, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 12, 2018
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
Jul 12, 2018	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Oct 10, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Jul 12, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209489
Drugs@FDA: Overview at FDA
Company: Cipla

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