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Draft BRANDNAME XR extended-release capsules Medication Guide MG received on September 19 2013 and received by DMPP on January 16 2014. DMEPA previously reviewed the proposed labels and labeling under OSE Review 2013-1237 dated October 21 2013. Silver Spring MD 20993 DBGLPC POC Ruben Ayala Pharm.D. Email ruben.ayala fda.hhs. gov TEL 301 796-2018 FAX 301 847-8748 cc CDER/OND/ODEI/DNP/Holmes/Chen/Dinsmore HFR-SW150/Turcovski Susan DIB HFR-SW1540/Martinez Joel BIMO HFR-SW1515/Alanna...
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