SOLIFENACIN SUCCINATE | N209529 | ASTELLAS PHARMA US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 5 Draft Guidance on Solifenacin Succinate re Suitability Petition ... FDA-2023-P-4326 · 12 docket documents Reguliance LLC, on behalf of Intas Third Party Sales 2005, S.L., filed a suitability petition regarding solifenacin succinate, requesting FDA guidance on the regulatory pathway and requirements for developing an abbreviated new drug application (ANDA) for a generic formulation of this drug product. | Suitability | 2023-10-03 | Denied | Intas Third Party Sales 2005, S.L. |
Suitability Petition from M A Pharmaceutical Consulting Inc FDA-2021-P-0567 · 5 docket documents 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.
Highest NADAC/Unit
$1.64
per ml
Lowest NADAC/Unit
$1.64
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51248025099VESICARE LS 5 MG/5 ML SUSP | $1.64 | ML | Brand | — | 2025-08-20 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9918970 | May 18, 2031 | — | — | Yes | — | — |