RIFAMPIN | N050420 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma, LLC FDA-2024-P-5469 Novitium Pharma LLC filed this relisting petition under sections 505(j) and 505(w) of the FDC Act and 21 C.F.R. sections 314.122 and 314.161 requesting that FDA determine whether RIFADIN (Rifampin) Capsules in 300mg (NDA N050420) and 150mg (A062303) strengths, owned by Sanofi Aventis US LLC, were vo | 505(q) | 2024-11-22 | Withdrawn | Novitium Pharma |
Citizen Petition from Novitium Pharma LLC FDA-2024-P-5470 Novitium Pharma LLC filed this relisting petition under 21 C.F.R. §10.25(a) and §10.30 and Sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether RIFADIN (Rifampin) Capsules, NDA N050420, owned by Sanofi Aventis US LLC, was voluntarily withdrawn from sale for reasons of | 505(q) | 2024-11-22 | Denied | Novitium Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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