APREPITANT | N021549 | MERCK SHARP AND DOHME LLC
| 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1 mg/mL (150 mg/150mL), a sterile single-use solution for intravenous infusion, is sui | Suitability | 2023-05-11 | Withdrawn | Neuheit Pharma Technologies Pvt Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8258132 | Sep 26, 2027 | — | — | Yes | — |