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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 | Methadose & Methadose Sugar-Free (methadone hydrochloride) Oral Concentrate, Mallinckrodt, Labeling Revision | Methadone Hydrochloride Tablets, Mallinckrodt, Approval | Methadose Oral Concentrate & Sugar-Free Oral Concentrate, Mallinckrodt, Control Supplement | Methadone HCl DISKETS Dispersible Tablets, Roxane Labs, Labeling Revision | Methadone Hydrochloride Tablets, Mallinckrodt, Control Suppl. | DISKETS Dispersible Tablets (methadone hydrochloride), Roxane Labs, Labeling Revision | Methadose Oral Concentrate (methadone hydrochloride) Oral Concentrate, and Methadose Sugar-Free Oral, Mallinckrodt Inc., Labeling Revision | Methadone Hydrochloride Tablets, The PharmaNetwork LLC, Approval | Methadone Hydrochloride Oral Solution, VistaPharm, Inc., Approval
  
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