← FDA DRUG APPROVALS

FDA NDA · NDA211988

ZYNRELEF

bupivacaine and meloxicam

Sponsor: HERON THERAPS INC

APPLICATION
NDA211988
TYPE
NDA
ORIGINAL APPROVAL
2021-05-12
LATEST ACTION
2025-04-17
ROUTE
INFILTRATION, PERIARTICULAR
DOSAGE FORM
SOLUTION, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued

Products

ZYNRELEF KIT · ReferencePrescription
BUPIVACAINE 200MG/7ML (29.25MG/ML), MELOXICAM 6MG/7ML (0.88MG/ML) · SOLUTION, EXTENDED RELEASE · PERIARTICULAR
ZYNRELEF KIT · ReferenceDiscontinued
BUPIVACAINE 300MG/10.5ML (29.25MG/ML), MELOXICAM 9MG/10.5ML (0.88MG/ML) · SOLUTION, EXTENDED RELEASE · PERIARTICULAR
ZYNRELEF KIT · ReferenceDiscontinued
BUPIVACAINE 60MG/2.3ML (29.25MG/ML), MELOXICAM 1.8MG/2.3ML (0.88MG/ML) · SOLUTION, EXTENDED RELEASE · PERIARTICULAR
ZYNRELEF KIT · ReferencePrescription
BUPIVACAINE 400MG/14ML (29.25MG/ML), MELOXICAM 12MG/14ML (0.88MG/ML) · SOLUTION, EXTENDED RELEASE · PERIARTICULAR

Approval history

2025-04-17Manufacturing (CMC) · Supplement 21 — Label ↗AP
2024-11-21Labeling · Supplement 18 · standard — Letter ↗AP
2024-09-24Manufacturing (CMC) · Supplement 16AP
2024-01-23Efficacy · Supplement 13 · standard — Letter ↗AP
2022-12-13Labeling · Supplement 10 · standardAP
2021-12-08Efficacy · Supplement 5 · standard — Letter ↗AP
2021-05-12Type 4 - New Combination · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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