RANOLAZINE | N021526 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research FDA-2025-P-3313 · 7 docket documents Premier Research filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Ranolazine Extended-release Tablets (750 mg) is suitable for submission in a supplemental Abbreviated New Drug Application (sANDA). The | Suitability | 2025-08-22 | Denied | Premier Research |
Citizen Petition from Lachman Consulting Services Inc. FDA-2025-P-0254 · 8 docket documents Lachman Consulting Services Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to declare that proposed Ranolazine Extended-Release Tablets in 375 mg and 750 mg strengths are suitable for submission as | Other | 2025-01-17 | Denied | Lachman Consulting Services Inc. |
Citizen Petition from Hyman, Phelps & McNamara, P C FDA-2018-P-3139 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of a client pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Ranolazine Extended-Release Tablets, 750 mg is suitable for submission in an Abbreviated New Drug Application, | Other | 2018-08-13 | Withdrawn | Hyman, Phelps & McNamara, P C |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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