PRUCALOPRIDE SUCCINATE | N210166 | TAKEDA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pilnova Pharma Inc. FDA-2026-P-4391 Pilnova Pharma Inc. filed this suitability petition on April 20, 2026, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting FDA approval to submit an Abbreviated New Drug Application for Prucalopride Orodispersible Films in 1 mg and 2 mg strengths, with MOTEGRITY | Suitability | 2026-04-21 | Open | Pilnova Pharma Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| M-14 | Jul 10, 2028 | Active |