PROTONIX IV

FDA-2018-P-1099 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition requesting that the FDA designate Pantoprazole Sodium Powder for IV infusion 40 mg base per vial marketed by Excela Pharma Sciences LLC (NDA 209463, approved via the 505(b)(2) pathway) as an additional reference listed drug, allowing generic appl

FDA-2017-P-4791 · 4 docket documents

Hyman, Phelps & McNamara, P.C. filed this citizen petition on behalf of Exela Pharma Sciences requesting that the FDA assign a Therapeutic Equivalence Code of "AP" in the Orange Book for Exela's Pantoprazole Sodium for Injection, 40 mg/vial, which was approved under NDA 209463 on June 30, 2017 pursu

FDA-2014-P-0142 · 4 docket documents

Emcure Pharmaceuticals USA Inc. filed this citizen petition on January 21, 2014, requesting that the FDA accept an Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection USP (equivalent to 40 mg pantoprazole) referencing a discontinued formulation of Protonix I.V. that require

FDA-2008-P-0649 · 3 docket documents

Strides Arcolab Limited filed this citizen petition under section 505(j)(2)(C) requesting FDA approval to proceed with an Abbreviated New Drug Application for a generic pantoprazole sodium 40 mg intravenous injection that substitutes sodium citrate for edetate disodium as the antioxidant, arguing th

FDA-2005-P-0082 · 5 docket documents

Sun Pharmaceutical Industries Ltd. submitted this citizen petition under section 505(j)(2)(C) requesting that the FDA determine that the discontinued formulation of Protonix I.V. for injection containing pantoprazole sodium (40 mg per vial requiring storage at 2°C-8°C) is suitable for submission as