LOVASTATIN | N019643 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Winifred Begley FDA-2015-P-3319 · 4 docket documents 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 · 16 docket documents 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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