FDA Approval Activities for this Drug…

Zyprexa (olanzapine) Tablets, 2.5, 5, 7.5, 10, 15 & 20 mg, Eli Lilly & Co. NDA 20-592/S18 7/10/03 7/28/03 7/10/03 Zyprexa Indications: Short-term treatment of acute manic episodes associated with Bipolar I Disorder, either as monotherapy (S-006) or in combination with lithium or valproate (S-018). Zyprexa (olanzapine) Tablets, Eli Lilly & Co. NDA 20-592/SE1-011 11/9/00 Zyprexa Zydis (olanzapine orally disintegrating) Tablets, Eli Lilly & Co. NDA 21-086 Symbyax (Olanzapine & Fluoxetine HCl) Capsules, Eli Lilly & Co., Inc. Zyprexa (olanzapine) Tablets, Eli Lilly & Co. Zyprexa IntraMuscular (olanzapine) Injection, Eli Lilly & Co. | Symbyax (olanzapine and fluoxetine HCl) Capsules, Eli Lilly and Co., Labeling Revision | Olanzapine Tablets, TEVA Pharma, Tentative Approval | Olanzapine Tablets, Mylan Pharma, Tentative Approval

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