CILASTATIN SODIUM; IMIPENEM; RELEBACTAM | N212819 | MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Peter Doshi FDA-2025-P-1575 · 3 docket documents Peter Doshi filed this citizen petition requesting that the FDA withdraw approval of Recarbrio (imipenem-cilastatin-relebactam) under NDA 212819 and 21 CFR § 314.150, arguing that the pivotal clinical trials submitted by Merck did not meet the legal requirement of substantial evidence from adequate | Other | 2025-06-05 | Open | Peter Doshi |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8487093 | Mar 21, 2033 | — | Yes | Yes | — |
| Code | Date | Status |
|---|---|---|
| GAIN | Jul 16, 2029 | Active |
| NCE | Jul 16, 2024 | Expired |
| NPP | Dec 9, 2028 | Active |