Tigecycline

ANDA 205722, held by Xellia Pharms Aps. Tigecycline.

As of Nov 15, 2026, ANDA 205722 (Tigecycline), held by Xellia Pharms Aps, was first approved by FDA on Oct 18, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 18, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 18, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tigecycline50MG/VIAL · powder;intravenous	Tigecycline	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 28, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Nov 28, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Oct 18, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 205722
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