METHYLPHENIDATE HYDROCHLORIDE | N018029 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition form MD Pharmaceutical Inc. FDA-1992-P-0169 · 3 docket documents MD Pharmaceutical Inc., a generic drug manufacturer, filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93 requesting that the FDA issue a finding that an abbreviated new drug application is suitable for Methylphenidate Hydrochloride Extende | Other | 2017-05-02 | Open | — |
Tedor Pharma Inc. - Citizen Petition FDA-2013-P-0303 · 4 docket documents Tedor Pharma Inc filed this citizen petition on March 6, 2013, pursuant to 21 CFR §314.161, requesting that the FDA determine whether UCB Inc's Metadate ER 10 mg (Methylphenidate Hydrochloride) Tablets (ANDA 040-306), which is listed as discontinued in the Orange Book, was voluntarily withdrawn for | Other | 2013-07-03 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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