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FDA Approval Activities for this Drug…
Naltrexone Hydrochloride Tablets, 25, 50 & 100mg, Mallinckrodt, ANDA 76-264 3/22/02 4/11/03 Naltrexone Hydrochloride Tablets, 50 mg Barr ANDA 74-918 5/8/98 5/8/98 3/19/99 Naltrexone Hydrochloride Tablets USP, 50 mg, Eon Labs Manufacturing, ANDA 75-434 3/8/00 3/9/00 12/6/01 Naltrexone Hydrochloride Tablets, 50 mg Amide Pharmaceutical, ANDA 75-274 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Amide 074918 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Barr 018932 NALTREXONE HYDROCHLORIDE Tablet; 50MG REVIA Barr 075434 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Eon 076264 NALTREXONE HYDROCHLORIDE Tablet; 100MG NALTREXONE HCL Mallinckrodt 076264 NALTREXONE HYDROCHLORIDE Tablet; 25MG NALTREXONE HCL Mallinckrodt 076264 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Mallinckrodt | Vivitrol (Naltrexone) Injectable Suspension, Alkermes, Inc., Approval | VIVITROL (naltrexone) Extended-release Injectable Suspension, Alkermes Inc., Labeling Revision | Embeda (morphine sulfate and naltrexone hydrocholride) Extended-Release Tablets, AlPharma Pharmaceuticals, Inc/King Pharmaceuticals, Approval | Vivitrol (naltrexone) Extended-Release Injectable Suspension, Alkermes, Inc., Labeling Revision | Vivitrol (naltrexone) Extended-Release Injection, Alkermes, Inc., Efficacy Supplement | Naltrexone Hydrochloride Tablets, Accord Healthcare, Inc., Approval
  
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