Safety Concerns Regarding Buprenorphine for Opioid Dependence-CLOSED
CDER buprenorphine opioid dependence reckitt benckiser pharmaceuticals rbp rld nda anda subutex suboxone hc1 naloxone child-resistant pediatric radars riskmap rems 2012-8052 CLOSED
2013-02-26 2012-12-11 2012-11-20
FDA-2012-P-1028-0014 FDA-2012-P-1028-0006 FDA-2012-P-1028-0005
05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0014 https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0006 https://api.regulations.gov/v4/comments/FDA-2012-P-1028-0005
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Actavis Inc. Comments to Docket No. FDA-2012-P-1028 (1-31-2013) This memo is submitted to provide a correction to the Reckitt Benckiser Pharmaceuticals -- Response to Amneal Comment (Doc ID: FDA-2012-P-1028-0005) Reckitt Benckiser Pharmaceuticals -- Response to Amneal Comment