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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211988

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ZYNRELEF KIT (BUPIVACAINE; MELOXICAM)
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE; MELOXICAM
Proprietary Name: ZYNRELEF KIT
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; PERIARTICULAR
Strength: 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211988
Product Number: 002
Approval Date: May 12, 2021
Applicant Holder Full Name: HERON THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYNRELEF KIT (BUPIVACAINE; MELOXICAM)
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE; MELOXICAM
Proprietary Name: ZYNRELEF KIT
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; PERIARTICULAR
Strength: 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211988
Product Number: 004
Approval Date: May 12, 2021
Applicant Holder Full Name: HERON THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYNRELEF KIT (BUPIVACAINE; MELOXICAM)
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)
Marketing Status: Discontinued
Active Ingredient: BUPIVACAINE; MELOXICAM
Proprietary Name: ZYNRELEF KIT
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; PERIARTICULAR
Strength: 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211988
Product Number: 001
Approval Date: May 12, 2021
Applicant Holder Full Name: HERON THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ZYNRELEF KIT (BUPIVACAINE; MELOXICAM)
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)
Marketing Status: Discontinued
Active Ingredient: BUPIVACAINE; MELOXICAM
Proprietary Name: ZYNRELEF KIT
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; PERIARTICULAR
Strength: 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211988
Product Number: 003
Approval Date: May 12, 2021
Applicant Holder Full Name: HERON THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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