METHYLPHENIDATE HYDROCHLORIDE | A078873 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petiton from Hyman, Phelps & McNamara, PC FDA-2018-P-2658 · 4 docket documents Hyman, Phelps & McNamara, PC filed this citizen petition requesting that FDA amend the Orange Book to designate ANDA 078873 as an additional reference standard for Methylphenidate Hydrochloride Capsules Extended Release 60 mg, because the current reference standard Metadate CD 60 mg (approved under | 505(q) | 2018-07-11 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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