NITAZOXANIDE | N021498 | ROMARK LABORATORIES
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Foley and Lardner LLP on behalf of Romark Laboratories,... FDA-2020-P-0513 Foley and Lardner LLP filed this citizen petition on behalf of Romark Laboratories, L.C., requesting that the FDA not approve any abbreviated new drug application for generic versions of ALINIA (nitazoxanide) tablets or oral suspension unless applicants conduct bioequivalence studies of both active | 505(q) | 2020-01-31 | Withdrawn | Foley and Lardner LLP on behalf of Romark Laboratories |
Citizen Petition from Foley and Lardner LLP on behalf of Romark Laboratories,... FDA-2020-P-0436 Foley and Lardner LLP on behalf of Romark Laboratories submitted this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA not approve any ANDA for generic versions of Alinia (nitazoxanide) tablets or oral suspension unless applicants cond | 505(q) | 2020-01-27 | Withdrawn | Foley and Lardner LLP on behalf of Romark Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.