FDA Approval for ZYNRELEF KIT issued to Heron Therapeutics, Inc.
$HRTX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211988
Company: Heron Therapeutics, Inc.
Company: Heron Therapeutics, Inc.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| Zynrelef | bupivacaine and meloxicam | 200MG/6MG | SOLUTION; INJECTION | Prescription | None | No | No |
| Zynrelef | bupivacaine and meloxicam | 300MG/9MG | SOLUTION; INJECTION | Prescription | None | No | No |
| Zynrelef | bupivacaine and meloxicam | 400MG/12MG | SOLUTION; INJECTION | Prescription | None | No | No |
| ZYNRELEF KIT | BUPIVACAINE; MELOXICAM | 60MG/1.8MG | SOLUTION;INJECTION | Prescription | TBD | TBD | No |
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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211988Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/12/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s000lbl.pdf |
Zynrelef
There are no Therapeutic Equivalents.
ZYNRELEF KIT
There are no Therapeutic Equivalents.