Dapzura Rt, Daptomycin In 0.9% Sodium Chloride

For right-sided infective endocarditis. NDA 213645, held by Baxter Hlthcare Corp. Daptomycin.

As of Nov 13, 2026, NDA 213645 (Dapzura Rt, Daptomycin In 0.9% Sodium Chloride), held by Baxter Hlthcare Corp, was first approved by FDA on Jan 25, 2022, with 3 approved supplements and 1 published complete response letter.

First approved: Jan 25, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

Daptomycin in Sodium Chloride Injection is a lipopeptide antibacterial indicated for the treatment of:

Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved and,
Staphylococcus aureus bloodstream infections (bacteremia), in adult patients for whom appropriate dosing can be achieved, including those with right-sided infective endocarditis,
Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 27, 2023	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 25, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Apr 29, 2021	DAPZURA RT (daptomycin)Non-Clinical	Approved

Products

5 strengths and forms

Product	Active ingredient	Marketing
Dapzura Rt500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intravenous	Daptomycin	DiscontinuedReference drug
Daptomycin In 0.9% Sodium Chloride350MG/50ML (7MG/ML) · solution;intravenous	Daptomycin	RxReference drug
Daptomycin In 0.9% Sodium Chloride500MG/50ML (10MG/ML) · solution;intravenous	Daptomycin	RxReference drug
Daptomycin In 0.9% Sodium Chloride700MG/100ML (7MG/ML) · solution;intravenous	Daptomycin	RxReference drug
Daptomycin In 0.9% Sodium Chloride1GM/100ML (10MG/ML) · solution;intravenous	Daptomycin	RxReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 24, 2026	Supplement 4Labeling · Standard review	Approved	Label Letter
Apr 30, 2025	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 27, 2023	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 25, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 213645
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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