METHYLPHENIDATE HYDROCHLORIDE | N021259 | AYTU BIOPHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Ascend Laboratories, LLC FDA-2018-P-2755 Ascend Laboratories, LLC filed this citizen petition on July 18, 2018, requesting that the FDA amend the Orange Book to designate any other approved generic version of Methylphenidate Hydrochloride Extended-Release Capsules (10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg) as an alternate reference sta | Other | 2018-07-18 | Denied | Ascend Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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