EMEND

FDA-2023-P-5655 · 13 docket documents

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 · 8 docket documents

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 · 3 docket documents

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

FDA-2017-P-4670 · 9 docket documents

Baxter Healthcare Corporation filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Merck's EMEND (fosaprepitant dimeglumine) 150 mg/vial, approved under NDA 022023, was reformulated for safety or effe