Zynrelef Kit

NDA 211988, held by Heron Theraps Inc. Bupivacaine; Meloxicam.

As of Nov 15, 2026, NDA 211988 (Zynrelef Kit), held by Heron Theraps Inc, was first approved by FDA on May 12, 2021, with 6 approved supplements and 2 published complete response letters.

First approved: May 12, 2021
Review: Priority
Supplements approved: 6
Complete response letters: 2

What It's For

From the FDA-approved label (Indications and Usage)

ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Jan 23, 2024	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 8, 2021	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
May 12, 2021	Original applicationNew combination · Priority review	Approved	Review Letter Label

Complete Response Letters

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


Jun 26, 2020	Zynrelef (bupivacaine and meloxicam)Nonclinical	Approved
Apr 30, 2019	Bupivacaine and MeloxicamProduct Quality, Nonclinical, Center For Devices And Radiologic Health	Approved

Products

4 strengths and forms


Zynrelef Kit60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) · solution, extended release;periarticular	Bupivacaine; Meloxicam	DiscontinuedReference drug
Zynrelef Kit200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) · solution, extended release;periarticular	Bupivacaine; Meloxicam	RxReference drug
Zynrelef Kit300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) · solution, extended release;periarticular	Bupivacaine; Meloxicam	DiscontinuedReference drug
Zynrelef Kit400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) · solution, extended release;periarticular	Bupivacaine; Meloxicam	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Apr 17, 2025	Supplement 21Manufacturing	Approved	Label Letter
Nov 21, 2024	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 24, 2024	Supplement 16Manufacturing	Approved	None posted
Jan 23, 2024	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 13, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Dec 8, 2021	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
May 12, 2021	Original applicationNew combination · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 211988
Drugs@FDA: Overview at FDA
Company: Heron Therapeutics

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