Tigecycline

ANDA 91620, held by Sandoz. Tigecycline.

As of Nov 15, 2026, ANDA 91620 (Tigecycline), held by Sandoz, was first approved by FDA on May 27, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: May 27, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for:

Complicated skin and skin structure infections
Complicated intra-abdominal infections
Community-acquired bacterial pneumonia Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline for injection and other antibacterial drugs, Tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 27, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Sep 15, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Jan 25, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Apr 9, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Apr 9, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Sep 29, 2017	Supplement 3Manufacturing	Approved	None posted
Sep 29, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Sep 29, 2017	Supplement 1Labeling · Standard review	Approved	None posted
May 27, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 91620
Drugs@FDA: Overview at FDA
Company: Sandoz

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