RIFAMPIN | N050420 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma, LLC FDA-2024-P-5469 · 4 docket documents 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in 300mg (NDA N050420) and 150mg (A062303) strengths, owned by Sanofi Aventis US LLC, were vo | 505(q) | 2024-11-22 | Withdrawn | Novitium Pharma, LLC |
Citizen Petition from Novitium Pharma LLC FDA-2024-P-5470 · 5 docket documents 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the FDA determine whether RIFADIN (Rifampin) Capsules, NDA N050420, owned by Sanofi Aventis US LLC, was voluntarily withdrawn from sale for reasons of | 505(q) | 2024-11-22 | Granted | Novitium Pharma LLC |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0662 · 2 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Rifampin Oral Suspension in strengths of 50 mg/5 mL and 100 mg/5 mL suitable for consideration in an abbreviated new drug application under Section 505(j)(2)(C), using Rifadin Capsules 300 mg | 505(q) | 2008-12-31 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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