Tyzavan

Treats septicemia. NDA 211962, held by Hikma. Vancomycin Hydrochloride.

As of Nov 14, 2026, NDA 211962 (Tyzavan), held by Hikma, was first approved by FDA on Feb 15, 2019, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 15, 2019
Review: Priority
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia Infective Endocarditis Skin and Skin Structure Infections Bone Infections Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Jun 27, 2025	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 28, 2021	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 15, 2019	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Letter Label

Products

7 strengths and forms


TyzavanEQ 500MG BASE/100ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
TyzavanEQ 1GM BASE/200ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
TyzavanEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
TyzavanEQ 2GM BASE/400ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
TyzavanEQ 750MG BASE/150ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
TyzavanEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug
TyzavanEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) · solution;intravenous	Vancomycin Hydrochloride	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Aug 18, 2026	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 27, 2025	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 26, 2025	Supplement 14Labeling · Standard review	Approved	Letter Label
May 28, 2021	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 29, 2021	Supplement 11Labeling · Standard review	Approved	Label Letter
Sep 3, 2020	Supplement 3Labeling · Standard review	Approved	Label Letter
Feb 15, 2019	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 211962
Drugs@FDA: Overview at FDA
Company: Hikma

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