Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.