Icatibant Acetate

ANDA 213222, held by Glenmark Pharms Ltd. Icatibant Acetate.

As of Nov 15, 2026, ANDA 213222 (Icatibant Acetate), held by Glenmark Pharms Ltd, was first approved by FDA on May 21, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: May 21, 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
May 21, 2021	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · injectable;subcutaneous	Icatibant Acetate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 2, 2022	Supplement 1Labeling · Standard review	Approved	None posted
May 21, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 213222
Drugs@FDA: Overview at FDA
Company: Glenmark 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