LOVASTATIN | N019643 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Winifred Begley FDA-2015-P-3319 Winifred Begley filed this citizen petition under 21 CFR 10.30 requesting that the FDA Commissioner determine whether Mevacor (lovastatin) tablets 20 mg and 40 mg (NDA 19643 of Merck & Co Inc.) were discontinued for reasons of safety or effectiveness, to enable potential 505(b)(2) applicants to refe | 505(q) | 2015-09-11 | Denied | Winifred Begley |
FDA/CFSAN Response to Pharmanex Inc - Answer FDA-1997-P-0065 Pharmanex Inc filed this administrative petition regarding Cholestin, a red yeast rice product containing lovastatin, seeking FDA confirmation that the product qualifies as a dietary supplement. The FDA concluded that Cholestin is not a dietary supplement but rather an unapproved new drug under the | Other | 2009-01-07 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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