EMEND

FDA-2023-P-5655

Neuheit Pharma Technologies Pvt Ltd filed this suitability petition requesting that the FDA declare Fosaprepitant Dimeglumine Ready to Use Injection, 1 mg/mL (150 mg/150 mL), a sterile single-use solution, suitable for consideration in an ANDA under section 505(j)(2)(C) of the FD&C Act. The petition

FDA-2023-P-1888

Neuheit Pharma Technologies Pvt Ltd filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA declare that Fosaprepitant Dimeglumine Ready to Use Injection, 1 mg/mL (150 mg/150mL), a sterile single-use solution for intravenous infusion, is sui

FDA-2019-P-4155

Teva Pharmaceuticals USA, Inc. filed this petition requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for Teva's Fosaprepitant Dimeglumine for Injection, Eq. 150 mg base/vial, which was approved under NDA 210064 on September 5, 2019, claiming it is ph