FDA Approval Activities for this Drug…

Diastat (diazepam rectal gel), Elan NDA 20-648/S-002 Valium (diazepam) Tablets & Injection, Roche Products NDA 13-263/S72/75 & 16-087/S79/81 2/7/02 4/16/02 Valium (diazepam) Tablets, 2 mg, 5 mg, and 10 mg Hoffmann-La Roche NDA 13-263/S-086 2/12/02 3/7/02 Valium (diazepam) Tablets, 2 mg, 5 mg, and 10 mg Hoffmann-La Roche NDA 13-263/S-082 DIAZEPAM Concentrate; 5MG/ML DIAZEPAM INTENSOL Roxane 020648 DIAZEPAM Gel; Rectal 10MG/2ML DIASTAT XCEL 020648 DIAZEPAM Gel; Rectal 15MG/3ML DIASTAT XCEL 020648 DIAZEPAM Gel; Rectal 2.5MG/0.5ML DIASTAT XCEL 020648 DIAZEPAM Gel; Rectal 20MG/4ML DIASTAT XCEL 020648 DIAZEPAM Gel; Rectal 5MG/ML DIASTAT XCEL 072079 DIAZEPAM Injection 5MG/ML DIAZEPAM Abbott 071583 DIAZEPAM Injection 5MG/ML DIAZEPAM Abbott 071584 DIAZEPAM Injection 5MG/ML DIAZEPAM Abbott 071309 DIAZEPAM Injection 5MG/ML DIAZEPAM Baxter 071310 DIAZEPAM Injection 5MG/ML DIAZEPAM Baxter 072370 DIAZEPAM Injection 5MG/ML DIAZEPAM MARSAM 072397 DIAZEPAM Injection 5MG/ML DIAZEPAM MARSAM 070296 DIAZEPAM Injection 5MG/ML DIAZEPAM STERIS 070928 DIAZEPAM Solution; 5MG/5ML DIAZEPAM Roxane 070154 DIAZEPAM Tablet; 10MG DIAZEPAM Barr 070152 DIAZEPAM Tablet; 2MG DIAZEPAM Barr 070153 DIAZEPAM Tablet; 5MG DIAZEPAM Barr 070226 DIAZEPAM Tablet; 2MG DIAZEPAM CLONMEL 070304 DIAZEPAM Tablet; 10MG DIAZEPAM Geneva 070302 DIAZEPAM Tablet; 2MG DIAZEPAM Geneva 070303 DIAZEPAM Tablet; 5MG DIAZEPAM Geneva 071322 DIAZEPAM Tablet; 10MG DIAZEPAM Ivax 071307 DIAZEPAM Tablet; 2MG DIAZEPAM Ivax 071321 DIAZEPAM Tablet; 5MG DIAZEPAM Ivax 070325 DIAZEPAM Tablet; 10MG DIAZEPAM Mylan 070323 DIAZEPAM Tablet; 2MG DIAZEPAM Mylan 070324 DIAZEPAM Tablet; 5MG DIAZEPAM Mylan 070464 DIAZEPAM Tablet; 10MG DIAZEPAM Par 070462 DIAZEPAM Tablet; 2MG DIAZEPAM Par 070463 DIAZEPAM Tablet; 5MG DIAZEPAM Par 070707 DIAZEPAM Tablet; 10MG DIAZEPAM Purepac 070781 DIAZEPAM Tablet; 2MG DIAZEPAM Purepac 070706 DIAZEPAM Tablet; 5MG DIAZEPAM Purepac 013263 DIAZEPAM Tablet; 10MG VALIUM ROCHE 013263 DIAZEPAM Tablet; 2MG VALIUM ROCHE 013263 DIAZEPAM Tablet; 5MG VALIUM ROCHE 071136 DIAZEPAM Tablet; 10MG DIAZEPAM Watson 071134 DIAZEPAM Tablet; 2MG DIAZEPAM Watson 071135 DIAZEPAM Tablet; 5MG DIAZEPAM Watson Diazepam Injection, Parenta Pharmaceuticals

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