Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has successfully filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for methenamine mandelate tablets USP, 500mg and 1,000mg. This filing joins another Edenbridge 505(b)(2) NDA already pending approval before the FDA for an orally disintegrating tablet (ODT) of glycopyrrolate filed in February 2021. “These two 505(b)(2) NDAs represent a significant achievement for Edenbridge, and we look forward to working with existing partners and identifying new ones to commercialize these products in the near future as our Company expands its footprint into branded prescription products” remarked Edenbridge’s CEO Ryan Collins. For more information, please contact the Company directly at info@dexcelpharmausa.com.
Methenamine Mandelate Tablets, USP Successful Filing
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To learn more about our specialty products, vigabatrin and Yargesa®, and how you may be able to save, please visit the Products page or navigate to a product-specific page.