General MedicationsPERIARTICULARStandard

ZYNRELEF KIT

BUPIVACAINE; MELOXICAM

Standard Dose

400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ZYNRELEF KIT is listed in Drugs@FDA under application 211988 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUPIVACAINE; MELOXICAM Form and strength SOLUTION, EXTENDED RELEASE;PERIARTICULAR - 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) Sponsor HERON THERAPS INC Submission history Latest submission status date: 2024-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZYNRELEF KIT is listed in Drugs@FDA under application 211988 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUPIVACAINE; MELOXICAM Form and strength SOLUTION, EXTENDED RELEASE;PERIARTICULAR - 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) Sponsor HERON THERAPS INC Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.