METHYLPHENIDATE HYDROCHLORIDE | N021475 | SPECGX LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2025-P-5439 Rising Pharma Holdings, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR Section 314.93, requesting FDA approval to submit an ANDA for Methylphenidate Hydrochloride Chewable Tablets, 20 mg, a strength that differs from the current | Suitability | 2025-10-17 | Open | Rising Pharma Holdings |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.