ARMODAFINIL | A200156 | WATSON LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen’s Health Research Group FDA-2025-P-1449 · 20 docket documents Public Citizen's Health Research Group filed this petition under the Federal Food, Drug, and Cosmetic Act sections 352 and 505(o)(4) requesting that the FDA contraindicate modafinil (PROVIGIL and generics) and armodafinil (NUVIGIL and generics) during pregnancy and in females of reproductive potenti | Other | 2025-05-29 | Open | Public Citizen’s Health Research Group |
Actavis, Inc. - Citizen Petition FDA-2010-P-0579 · 7 docket documents Actavis, Inc. filed this citizen petition on November 9, 2010, requesting that the FDA determine that Nuvigil (armodafinil) Tablets in 100 mg and 200 mg strengths, approved under NDA 21-875 and discontinued in February 2010, were not voluntarily withdrawn for safety or efficacy reasons, as required | 505(q) | 2010-11-22 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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