FDA Approval Activities for this Drug…

Ativan (Lorazepam) Injection, Wyeth NDA 96-989/S35 & S36 Lorazepam Injection USP, 2 mg/mL (syringe), Taylor ANDA 75-974 7/23/98 7/23/98 1/10/02 Lorazepam Injection USP, 2 mg/mL (vial), Taylor ANDA 75-025 7/23/98 7/23/98 9/25/02 Lorazepam Injection USP, 2 mg/mL & 4mg/mL, Mova Pharmaceutical Corp. ANDA 74-793 3/16/00 3/21/00 1/15/02 Lorazepam Injection USP, 2 mg/mL and 4 mg/mL, Elkins-Sinn ANDA 74-496 9/28/98 9/28/98 8/4/03 Lorazepan Tablets USP, 0.5, 1 & 2 mg, Ranbaxy Ltd. ANDA 76-045 LORAZEPAM Concentrate; 2MG/ML LORAZEPAM INTENSOL Roxane 074300 LORAZEPAM Injection 2MG/ML LORAZEPAM Abbott 074282 LORAZEPAM Injection 2MG/ML LORAZEPAM Abbott 074243 LORAZEPAM Injection 2MG/ML LORAZEPAM Abbott 074280 LORAZEPAM Injection 2MG/ML LORAZEPAM Abbott 074280 LORAZEPAM Injection 4MG/ML LORAZEPAM Abbott 074243 LORAZEPAM Injection 4MG/ML LORAZEPAM Abbott 074282 LORAZEPAM Injection 4MG/ML LORAZEPAM Abbott 074300 LORAZEPAM Injection 4MG/ML LORAZEPAM Abbott 074974 LORAZEPAM Injection 2MG/ML LORAZEPAM Akorn 018140 LORAZEPAM Injection 2MG/ML ATIVAN Baxter CORP 018140 LORAZEPAM Injection 4MG/ML ATIVAN Baxter CORP 074793 LORAZEPAM Injection 2MG/ML LORAZEPAM CLONMEL 074793 LORAZEPAM Injection 4MG/ML LORAZEPAM CLONMEL 074496 LORAZEPAM Injection 2MG/ML LORAZEPAM ELKINS SINN 074496 LORAZEPAM Injection 4MG/ML LORAZEPAM ELKINS SINN 074551 LORAZEPAM Injection 1MG/0.5ML LORAZEPAM MARSAM 074535 LORAZEPAM Injection 2MG/ML LORAZEPAM MARSAM 074551 LORAZEPAM Injection 2MG/ML LORAZEPAM MARSAM 074551 LORAZEPAM Injection 4MG/ML LORAZEPAM MARSAM 074535 LORAZEPAM Injection 4MG/ML LORAZEPAM MARSAM 074276 LORAZEPAM Injection 2MG/ML LORAZEPAM STERIS 074276 LORAZEPAM Injection 4MG/ML LORAZEPAM STERIS 075025 LORAZEPAM Injection 2MG/ML LORAZEPAM TAYLOR 074648 LORAZEPAM Solution; 0.5MG/5ML LORAZEPAM Roxane 017794 LORAZEPAM Tablet; 0.5MG ATIVAN BIOVAIL 017794 LORAZEPAM Tablet; 1MG ATIVAN BIOVAIL 017794 LORAZEPAM Tablet; 2MG ATIVAN BIOVAIL 071193 LORAZEPAM Tablet; 0.5MG LORAZEPAM Geneva 071194 LORAZEPAM Tablet; 1MG LORAZEPAM Geneva 071195 LORAZEPAM Tablet; 2MG LORAZEPAM Geneva 072553 LORAZEPAM Tablet; 0.5MG LORAZEPAM Mutual 072554 LORAZEPAM Tablet; 1MG LORAZEPAM Mutual 072555 LORAZEPAM Tablet; 2MG LORAZEPAM Mutual 071589 LORAZEPAM Tablet; 0.5MG LORAZEPAM Mylan 071590 LORAZEPAM Tablet; 1MG LORAZEPAM Mylan 071591 LORAZEPAM Tablet; 2MG LORAZEPAM Mylan 071403 LORAZEPAM Tablet; 0.5MG LORAZEPAM Purepac 071404 LORAZEPAM Tablet; 1MG LORAZEPAM Purepac 071141 LORAZEPAM Tablet; 2MG LORAZEPAM Purepac 076045 LORAZEPAM Tablet; 0.5MG LORAZEPAM Ranbaxy 076045 LORAZEPAM Tablet; 1MG LORAZEPAM Ranbaxy 076045 LORAZEPAM Tablet; 2MG LORAZEPAM Ranbaxy 071117 LORAZEPAM Tablet; 0.5MG LORAZEPAM Watson 072926 LORAZEPAM Tablet; 0.5MG LORAZEPAM Watson 072927 LORAZEPAM Tablet; 1MG LORAZEPAM Watson 071118 LORAZEPAM Tablet; 1MG LORAZEPAM Watson 071087 LORAZEPAM Tablet; 1MG LORAZEPAM Watson 071088 LORAZEPAM Tablet; 2MG LORAZEPAM Watson 071110 LORAZEPAM Tablet; 2MG LORAZEPAM Watson 072928 LORAZEPAM Tablet; 2MG LORAZEPAM Watson Lorazepam Injection, International Medication Systems, Approval

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