METHYLPHENIDATE HYDROCHLORIDE | A089601 | LANNETT CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from ABHAI, LLC FDA-2016-P-1247 · 4 docket documents ABHAI, LLC filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA revise its February 2010 Bioequivalence Guidance for Methylphenidate Hydrochloride Extended Release Tablets 20 mg to require partial AUC calculations for establ | 505(q) | 2016-05-10 | Withdrawn | ABHAI, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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