LEVONORGESTREL | N021045 | FOUNDATION CONSUMER HEALTHCARE LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kleinfeld Kaplan Becker (on behalf of Taiho Oncology, I... FDA-2022-P-0155 Kleinfeld Kaplan Becker filed this citizen petition on behalf of Taiho Oncology, Inc., the NDA holder for Lonsurf (trifluridine and tipiracil) tablets. Taiho requests that FDA refuse to approve any ANDA for generic trifluridine and tipiracil tablets that omit the pharmacokinetic information and dosa | 505(q) | 2022-02-10 | Denied | Kleinfeld Kaplan Becker (on behalf of Taiho Oncology |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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