VESICARE LS

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

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.

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

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.

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