NDA 21-515 Approval Letter 7
If
you have any questions, please call Doris J. Bates, Ph.D., Regulatory Project
Manager, at 301-594-2850.
Sincerely,
{see appended electronics signature page}
Russell Katz, M.D.
Director
Division of Neuropharmacological Drug Products
Office of Drug Evaluation I
Center for Drug Evaluation and Research
Enclosure
(Revised Draft Labeling) [Please note: the electronic signature page will
follow the labeling.]
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