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FDA Approval Activities for this Drug…
TEMODAR (Temozolomide) Capsules, Schering NDA 21-029/S5 3/11/03 3/25/03 3/25/03 TEMODAR (Temozolomide) Capsules, Schering NDA 21-029/S4 1/18/02 2/5/02 11/18/02 TEMODAR (Temozolomide) Capsules, 250 mg;100mg; 20 mg; 5 mg, Schering NDA 21-029 8/11/99 9/24/99 8/24/99 7/3/00 Temodar Indication: treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. Temodar (temozolomide) Capsules, Schering Corporation, Labeling Revision Temodar (temozolomide) Capsules, Schering Corporation, Labeling Revision | Temodar (temozolomide) Capsules, Schering Corp, New or Modified Indication | Temodar (temozolomide) Capsules, Schering Corp., Labeling Revision | Temodor (Temozolomide) Capsules, Schering Corp., Labeling Revision | Temodar (temozolomide) Capsules, Schering Corp., Labeling Revision | Temodar (temozolomide) Capsules, Schering Corp., Manufacturing Change or Addition | Temodar (temozolomide) Injection, Schering Corp., Approval | Temozolomide Capsules, Barr Laboratories, Inc., Approval | Temodar (temozolomide) Powder, Schering-Plough Corp., Labeling Revision | Temodar (temozolomide) Capsules, Schering-Plough Corp., Labeling Revision | Temodar (temozolomide) I.V. Powder, Schering Corp., Labeling Revision | Temodar (temozolomide) Capsules, Schering Corporation, Labeling Revision | Temodar (temozolomide) Injection, Schering Corp., Labeling Revision
  
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