SOLIFENACIN SUCCINATE | N021518 | ASTELLAS PHARMA US INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2018-06-25 | Terminated 2018-09-24 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| 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 | — |
| Suitability | 2023-10-03 | Denied | Intas Third Party Sales 2005, S.L. | |
Suitability Petition from Reguliance LLC on behalf of Intas Third Party Sales... FDA-2023-P-4326 Reguliance LLC, on behalf of Intas Third Party Sales 2005, S.L., filed this ANDA suitability petition pursuant to section 505(j)(2)(C) requesting that the FDA determine that Solifenacin Succinate 5 mg and 10 mg orally disintegrating tablets are suitable for submission in an Abbreviated New Drug Appl | Suitability | 2023-10-03 | Denied | Intas Third Party Sales 2005, S.L. |
Attachment 5 Draft Guidance on Solifenacin Succinate re Suitability Petition ...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 |
Citizen Petition from Reguliance LLC on behalf of INTAS Pharmaceuticals, Ltd. FDA-2019-P-4645 Reguliance LLC on behalf of INTAS Pharmaceuticals, Ltd. filed an ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Solifenacin Succinate 5 mg and 10 mg orally disintegrating tablets are suitable for submission in | Other | 2019-10-04 | Withdrawn | INTAS Pharmaceuticals, Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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