RAMIPRIL | N219757 | ROSEMONT PHARMACEUTICALS HOLDINGS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
King Pharmaceuticals - Citizen Petition FDA-2008-P-0304 · 3 docket documents King Pharmaceuticals, Inc. filed this citizen petition on May 16, 2008, requesting that FDA confirm it will ensure generic ramipril products approved under ANDA applications referencing Altace include complete cardiovascular outcomes labeling information from the HOPE trial regarding reduction of ri | 505(q) | 2008-06-04 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 12343338 | Aug 16, 2039 | — | — | Yes | — |