Application 211988
- Type
- NDA
- Sponsor
- Heron Therapeutics, Inc.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | Zynrelef | bupivacaine and meloxicam | SOLUTION;INJECTION | 60MG/1.8MG | No | No |
| 002 | Zynrelef | bupivacaine and meloxicam | SOLUTION; INJECTION | 200MG/6MG | No | No |
| 003 | Zynrelef | bupivacaine and meloxicam | SOLUTION; INJECTION | 300MG/9MG | No | No |
| 004 | Zynrelef | bupivacaine and meloxicam | SOLUTION; INJECTION | 400MG/12MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47426-301 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-301 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-301 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-302 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-302 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-302 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-303 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-303 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-303 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-304 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-304 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
| 47426-304 | ZYNRELEF | BUPIVACAINE and MELOXICAM | Heron Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85651 | SUPPL | 2026-04-07 |
| 85650 | SUPPL | 2026-04-07 |
| 80401 | SUPPL | 2024-11-25 |
| 80318 | SUPPL | 2024-11-22 |
| 77885 | SUPPL | 2024-03-21 |
| 77297 | SUPPL | 2024-01-25 |
| 77284 | SUPPL | 2024-01-24 |
| 71469 | SUPPL | 2022-06-28 |
| 70687 | ORIG | 2022-04-05 |
| 69526 | SUPPL | 2021-12-10 |
| 69520 | SUPPL | 2021-12-09 |
| 67484 | ORIG | 2021-05-13 |
| 67481 | ORIG | 2021-05-13 |