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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211988
Company: HERON THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYNRELEF KIT BUPIVACAINE; MELOXICAM 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) SOLUTION, EXTENDED RELEASE;PERIARTICULAR Discontinued None Yes No
ZYNRELEF KIT BUPIVACAINE; MELOXICAM 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) SOLUTION, EXTENDED RELEASE;PERIARTICULAR Prescription None Yes Yes
ZYNRELEF KIT BUPIVACAINE; MELOXICAM 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) SOLUTION, EXTENDED RELEASE;PERIARTICULAR Discontinued None Yes No
ZYNRELEF KIT BUPIVACAINE; MELOXICAM 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) SOLUTION, EXTENDED RELEASE;PERIARTICULAR Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/12/2021 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211988Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/211988Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2021 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211988Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/211988Orig1s005.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2021 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s005lbl.pdf
05/12/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s000lbl.pdf
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