ESOMEPRAZOLE MAGNESIUM; NAPROXEN | A204206 | DR REDDYS LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Horizon Pharma, Inc. FDA-2014-P-0209 Horizon Pharma, Inc. filed this citizen petition on February 3, 2014, requesting that the FDA require any Abbreviated New Drug Application for a generic version of VIMOVO (naproxen/esomeprazole magnesium) that does not completely enterically coat the naproxen component to be supported by either equ | 505(q) | 2014-03-07 | Denied | Horizon Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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