Application 209776
- Type
- NDA
- Sponsor
- REMPEX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VABOMERE | MEROPENEM; VABORBACTAM | POWDER;INTRAVENOUS | 1GM/VIAL;1GM/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65293-009 | VABOMERE | Meropenem-Vaborbactam | The Medicines Company | NDA | Current |
| 70842-120 | VABOMERE | Meropenem-Vaborbactam | Melinta Therapeutics, Inc. | NDA | Current |
| 70842-120 | VABOMERE | Meropenem-Vaborbactam | Melinta Therapeutics, Inc. | NDA | Current |
| 70842-120 | VABOMERE | Meropenem-Vaborbactam | Melinta Therapeutics, Inc. | NDA | Current |
| 70842-120 | VABOMERE | Meropenem-Vaborbactam | Melinta Therapeutics, LLC | NDA | Current |
| 70842-120 | VABOMERE | Meropenem-Vaborbactam | Melinta Therapeutics, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85130 | SUPPL | 2026-02-24 |
| 85111 | SUPPL | 2026-02-24 |
| 80519 | SUPPL | 2024-12-05 |
| 80499 | SUPPL | 2024-12-04 |
| 75542 | SUPPL | 2023-09-22 |
| 75531 | SUPPL | 2023-09-22 |
| 63339 | SUPPL | 2020-05-29 |
| 63324 | SUPPL | 2020-05-28 |
| 54883 | SUPPL | 2018-07-13 |
| 54864 | SUPPL | 2018-07-09 |
| 49936 | ORIG | 2017-10-04 |
| 49614 | ORIG | 2017-08-30 |
| 49613 | ORIG | 2017-08-30 |