Drug Export; ReviaSUPTM (Naltrexone Hydrochloride (HCl)) 50 Milligrams (mg) Film-Coated Tablets

Короткий зміст

The Food and Drug Administration (FDA) is announcing that Dupont Merck has filed an application requesting approval for the export of the human drug Revia TM (naltrexone HCl) 50 mg film- coated tablets to Germany. ADDRESSES: Relevant information on this application may be directed to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and to the contact person identified below. Any future inquiries concerning the export of human drugs under the Drug Export Amendments Act of 1986 should also be directed to the contact person.