FOSAPREPITANT DIMEGLUMINE | N210064 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Neuheit Pharma Technologies Pvt Ltd FDA-2023-P-5655 · 13 docket documents Neuheit Pharma Technologies Pvt Ltd filed this ANDA suitability petition under section 505(j)(2)(C) for Fosaprepitant Dimeglumine Ready to Use Injection, 1 mg/mL (150 mg/150mL), requesting a waiver of pediatric assessment requirements under the Pediatric Research Equity Act and arguing that in vivo | Suitability | 2024-02-05 | Granted | — |
Suitability Petition from Neuheit Pharma Technologies Pvt Ltd. 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1 mg/mL (150 mg/150mL), a sterile single-use solution for intravenous infusion, is sui | Suitability | 2023-05-11 | Withdrawn | Neuheit Pharma Technologies Pvt Ltd. |
Citizen Petition from Teva Pharmaceuticals USA, Inc 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 | Other | 2019-09-06 | Open | Teva Pharmaceuticals USA, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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