FDA Approval Activities for this Drug…

Methadone HCl oral Concentrate, 10 mg/ml Roxane ANDA 40-180 5/6/98 Methadone HCL Tablets,5mg, 10 mg Eon Labs ANDA 40-241 5/29/98 6/3/98 2/22/99 Methadone Hydrochloride Tablets USP, 40 mg (Dispersible). Eon Labs Manufacturing, ANDA 75-082 3/25/98 3/22/99 Methadose (Methadone Hydrochloride) Concentrate, USP, 10 mg/mL. Mallinckrodt, Inc NDA 17-116/S-014 METHADONE HYDROCHLORIDE Concentrate; 10MG/ML METHADOSE Mallinckrodt 040180 METHADONE HYDROCHLORIDE Concentrate; 10MG/ML METHADONE HCL Roxane 089897 METHADONE HYDROCHLORIDE Concentrate; 10MG/ML METHADONE HCL INTENSOL Roxane 040088 METHADONE HYDROCHLORIDE Concentrate; 10MG/ML METHADONE HCL UDL 021624 METHADONE HYDROCHLORIDE Injection 10MG/ML DOLOPHINE HCL AAIPHARMA 006383 METHADONE HYDROCHLORIDE Powder; For Compounding 100GM/BOT METHADONE HCL Mallinckrodt 006383 METHADONE HYDROCHLORIDE Powder; For Compounding 500GM/BOT METHADONE HCL Mallinckrodt 006383 METHADONE HYDROCHLORIDE Powder; For Compounding 50GM/BOT METHADONE HCL Mallinckrodt 087997 METHADONE HYDROCHLORIDE Solution; 10MG/5ML METHADONE HCL Roxane 087393 METHADONE HYDROCHLORIDE Solution; 5MG/5ML METHADONE HCL Roxane 040241 METHADONE HYDROCHLORIDE Tablet; 10MG METHADONE HCL Eon 075082 METHADONE HYDROCHLORIDE Tablet; 40MG METHADONE HCL Eon 040241 METHADONE HYDROCHLORIDE Tablet; 5MG METHADONE HCL Eon 040050 METHADONE HYDROCHLORIDE Tablet; 10MG METHADOSE Mallinckrodt 074184 METHADONE HYDROCHLORIDE Tablet; 40MG METHADOSE Mallinckrodt 040050 METHADONE HYDROCHLORIDE Tablet; 5MG METHADOSE Mallinckrodt 006134 METHADONE HYDROCHLORIDE Tablet; 10MG DOLOPHINE HCL Roxane 088109 METHADONE HYDROCHLORIDE Tablet; 10MG METHADONE HCL Roxane 017058 METHADONE HYDROCHLORIDE Tablet; 40MG METHADONE HCL Roxane 074081 METHADONE HYDROCHLORIDE Tablet; 40MG METHADONE HCL Roxane 006134 METHADONE HYDROCHLORIDE Tablet; 5MG DOLOPHINE HCL Roxane 088108 METHADONE HYDROCHLORIDE Tablet; 5MG METHADONE HCL Roxane Methadone HCl Injection, aaiPharma, Inc. Methadone HCL Tablets, Mallinckrodt

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