SOLIFENACIN SUCCINATE | A091464 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Completeness Assessment Correspondence from FDA CDER to ... FDA-2023-P-4326 Reguliance LLC filed a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an Abbreviated New Drug Application for Solifenacin Succinate Orally Disintegrating Tablet in 5 mg and 10 mg strengths. The FDA determined the petition complete and assigned a review goal date of A | Suitability | 2023-10-11 | Denied | — |
Attachment 5 Draft Guidance on Solifenacin Succinate re Suitability Petition ... FDA-2023-P-4326 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. |
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 |
Attachment 3 Proposed label for Solifenacin Succinate Oral Solution re Suitab... FDA-2021-P-0567 M A Pharmaceutical Consulting Inc filed a suitability petition regarding Solifenacin Succinate Oral Solution, proposing a revised product label for this anticholinergic medication used to treat overactive bladder. The petition seeks FDA review and approval of the proposed labeling changes under the | Suitability | 2021-07-07 | Open | M A Pharmaceutical Consulting Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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