DANTROLENE SODIUM | N017443 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-1403 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Dantrolene Sodium Orally Disintegrating Tablets in 25 mg, 50 mg, and 100 mg strengths suitable for submission in | Suitability | 2024-03-21 | Open | Pharmobedient Consulting |
Citizen Petition from Elite Laboratories Inc FDA-2017-P-5954 Elite Laboratories, Inc. filed this petition under 21 CFR 314.122 requesting that the FDA determine Dantrolene Sodium 100 mg (ANDA 076856, manufactured by Impax Laboratories) is suitable as a Reference Listed Drug because the current Orange Book RLD, Dantrium 100 mg (Par Sterile Products LLC, NDA 17 | Other | 2017-09-27 | Denied | Elite Laboratories Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.