SOLIFENACIN SUCCINATE | N209529 | ASTELLAS PHARMA US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Vesicare LS Solifenacin Succinate Oral Suspension re Suitability... FDA-2021-P-0567 M A Pharmaceutical Consulting Inc filed a citizen petition requesting FDA confirmation of suitability regarding Vesicare LS (solifenacin succinate oral suspension), seeking regulatory acknowledgment that the formulation is suitable for approval and commercialization under applicable NDA procedures. | Suitability | 2021-07-07 | Open | M A Pharmaceutical Consulting Inc |
Suitability Petition from M A Pharmaceutical Consulting Inc FDA-2021-P-0567 M A Pharmaceutical Consulting Inc., on behalf of Liqmeds Limited, submitted this suitability petition under 21 CFR 314.93 requesting FDA determination that an ANDA can be submitted for Solifenacin Succinate Oral Solution, 1 mg/mL, which would differ from the reference listed drug Vesicare LS (Solife | Suitability | 2021-07-07 | Open | M A Pharmaceutical Consulting Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9918970 | May 18, 2031 | — | — | Yes | — | — |