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FDA Approval Activities for this Drug…
Methotrexate Sodium Injection, Wyeth NDA 11-719/S-105 7/29/03 8/6/03 | Methotrexate Sodium Injection, Wyeth-Ayerst NDA 11-719/S-104 1/3/03 1/23/03 | Methotrexate Sodium Tablets, Clonmel Healthcare NDA 8-085/S55 & S52 10/24/03 | Methotrexate Sodium Tablets, Sodium for Injection and Sodium Injection. Wyeth-Ayerst NDA 8-085/S-053/S-054 & 11-719/S-102/S-103 2/20/02 2/21/02 | Methotrexate Injection USP, 25 mg/mL, 2 mL & 10 mL Bigmar ANDA 40-263 2/26/99 3/2/99 8/4/03 | Methotrexate Injection USP, 25 mg/mL in vials of 50 mg, 100 mg, 200 mg, & 250 mg Bigmar ANDA 40-265 2/26/99 3/2/99 8/4/03 | Methotrexate Injection USP, 1 g/vial Bigmar ANDA 40-266 2/26/99 3/2/99 8/4/03 | Methotrexate Tablets USP, 2.5 mg. Duramed ANDA 40-233 Trexall (Methotrexate) Tablets USP, 5 mg, 7.5 mg, 10 mg, & 15 mg, Barr, ANDA 40-385 Methotrexate Sodium Tablets, Clonmel Healthcare METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM Bedford 089341 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM Bedford 089342 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM Bedford 089343 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM Bedford 040266 METHOTREXATE SODIUM Injection 1GM BASE/VIAL METHOTREXATE PRESERVATIVE FREE BIGMAR | 040263 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE BIGMAR | 040265 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE PRESERVATIVE FREE BIGMAR | 088760 METHOTREXATE SODIUM Injection 25MG BASE/ML MEXATE-AQ BRISTOL MYERS | 088648 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM NORBROOK | 089158 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM Pharmachemie USA | 087695 METHOTREXATE SODIUM Injection 100MG BASE/VIAL FOLEX PHARMACIA AND UPJOHN | 088954 METHOTREXATE SODIUM Injection 250MG BASE/VIAL FOLEX PHARMACIA AND UPJOHN | 087695 METHOTREXATE SODIUM Injection 25MG BASE/VIAL FOLEX PHARMACIA AND UPJOHN | 087695 METHOTREXATE SODIUM Injection 50MG BASE/VIAL FOLEX PHARMACIA AND UPJOHN | 011719 METHOTREXATE SODIUM Injection 1GM BASE/VIAL METHOTREXATE SODIUM PRESERVATIVE FREE Wyeth INC | 011719 METHOTREXATE SODIUM Injection 20MG BASE/VIAL METHOTREXATE SODIUM Wyeth INC | 011719 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE SODIUM Wyeth INC | 011719 METHOTREXATE SODIUM Injection 25MG BASE/ML METHOTREXATE LPF Wyeth INC | 040385 METHOTREXATE SODIUM Tablet; 10MG BASE TREXALL Barr | 040385 METHOTREXATE SODIUM Tablet; 15MG BASE TREXALL Barr | 081099 METHOTREXATE SODIUM Tablet; 2.5MG BASE METHOTREXATE SODIUM Barr | 040385 METHOTREXATE SODIUM Tablet; 5MG BASE TREXALL Barr | 040385 METHOTREXATE SODIUM Tablet; 7.5MG BASE TREXALL Barr 008085 METHOTREXATE SODIUM Tablet; 2.5MG BASE METHOTREXATE SODIUM CLONMEL | 040233 METHOTREXATE SODIUM Tablet; 2.5MG BASE METHOTREXATE SODIUM DURAMED Barr | 081235 METHOTREXATE SODIUM Tablet; 2.5MG BASE METHOTREXATE SODIUM Mylan | 040054 METHOTREXATE SODIUM Tablet; 2.5MG BASE METHOTREXATE SODIUM Roxane | Methotrexate Sodium Injection, Wyeth Pharmaceuticals | Methotrexate Injection, Mayne Pharma, Manufacturing Change or Addition | Methotrexate Injection, Bedford Labs, Approval | Methotrexate Sodium Tablets, Clonmel Healthcare, Labeling Revision | Methotrexate Injection, GeneraMedix Inc., Approval | Methotrexate Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval | Rheumatrex (methotrexate sodium) Tablets, Dava Pharmaceuticals, Inc., Manufacturing Change or Addition | Methotrexate Sodium Preservative Free (methotrexate sodium) Injection, Pharmachemie B.V., Approval | Methotrexate LPF (methotrexate sodium) Injection, Hospira, Inc., Labeling Revision | Methotrexate Preservative Free (methotrexate sodium) Injection, Hospira, Inc., Labeling Revision | Methotrexate Sodium Injection, Hospira, Inc., Labeling Revision | Methotrexate Sodium Preservative Free (methotrexate sodium) Injection, Hospira, Inc., Labeling Revision
  
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