VESICARE

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

FDA-2023-P-4326

I cannot provide a meaningful summary of this petition as the document content provided consists only of a title/header with no substantive information about the petition details, requested actions, regulatory mechanisms, or specific grounds for the request. To create an accurate summary meeting you

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 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

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-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