FDA Approval for ZYNRELEF KIT issued to HERON THERAPS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211988
Company: HERON THERAPS INC
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 |
|---|---|---|---|---|---|
| 01/23/2024 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/13/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 |