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OLANZAPINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

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 | Zyprexa (olanzapine) tablets, Eli Lilly and Co., Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision | Zyprexa Zydis (olanzapine) orally disintegrating tablets, Eli Lilly and Co., Labeling Revision | Zyprexa IntraMuscular (olanzapine for injection), Eli Lilly and Co., Labeling Revision | Olanzapine Tablets, Sandoz Inc., Tentative Approval | Zyprexa (olanzapine) tablets, Eli Lilly and Co., Labeling Revision | Zyprexa Zydis (olanzapine) orally disintegrating tablets, Eli Lilly and Co., Labeling Revision | Zyprexa IntraMuscular (olanzapine) injection, Eli Lilly and Co., Labeling Revision | Symbyax (olanzapine and fluoxetine HCl) capsules, Eli Lilly & Co., Labeling Revision | Zyprexa Tablet, Lilly, Labeling Revision | Zyprexa Injection, Lilly, Labeling Revision | Zyprexa Zydis Tablet, Lilly, Labeling Revision | Symbyax (olanzapine/fluoxetine) capsules, Eli Lilly, Labeling Revision | Olanzapine Tablets, Roxane Labs, Tentative Approval | Olanzapine Orally Disintegrating Tablets, Barr Labs, Tentative Approval | Symbyax (olanzapine and fluoxetine HCl) capsules, Eli Lilly, Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly, Labeling Revision | Zyprexa Zydis (olanzapine) orally disintegrating tablets, Eli Lilly, Labeling RevisionZyprexa IntraMuscular (olanzapine) injection, Eli Lilly, Labeling Revision | SYMBYAX (olanzapine and fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly & Co., Labeling Revision | Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly & Co., Labeling Revision | Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly & Co., Labeling Revision | Olanzapine and Fluoxetine Hydrochloride Capsules, Teva Pharma, Tentative Approval | Symbyax (olanzapine/fluoxetine HCl) capsules, Eli Lilly Co., Labeling Revision | Symbyax (fluoxetine hydrochloride; olanzapine) Capsules, Eli Lilly and Co., Labeling Revision | Symbyax (olanzapine/fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision | Symbyax (fluoxetine hydrochloride and olanzapine) Capsules, Eli Lilly and Co., Labeling Revision | Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision | Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision | Olanzapine Tablets, Roxane Labs, Tentative Approval | Symbyax (olanzapine and fluoxetine) Capsules, Eli Lilly and Co., Efficacy Supplement with Clinical Data to Support | Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Efficacy Supplement with Clinical Data To Support | Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Efficacy Supplement with Clinical Data to Support | Olanzapine Tablets, Dr. Reddy's Laboratories, Inc., Tentative Approval | Olanzapine Tablets, Dr. Reddy's Laboratories Limited, Tentative Approval | Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Efficacy Supp. w/Clinical Data | Zyprexa Relprevv (olanzapine) Injection, Eli Lilly, Approval | Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision | Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Company, Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Labeling Revision | Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Company, Labeling Revision | Zyprexa Relprevv (olanzapine pamoate) Extended-Release Intramuscular Suspension, Eli Lilly and Company, Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision | Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision | Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision | Zyprexa Relprevv (olanzapine pamoate) Extended-Release Intramuscular Suspension, Eli Lilly and Co., Labeling Revision | Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision | Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision | Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Labeling Revision | Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Company, Labeling Revision | Symbyax (fluoxetine hydrochloride and olanzapine) Capsule, Eli Lilly and Co., Labeling Revision | Olanzapine Intramuscular Injection, InnoPharma LLC, Approval | Olanzapine Orally Disintegrating Tablets, Apotex Inc., Approval | Olanzapine Orally Disintegrating Tablets, Par Pharmaceutical, Inc., Approval | Olanzapine Tablets, TEVA Pharmaceuticals USA, Approval | Olanzapine Tablets, Dr. Reddy’s Laboratories Ltd., Approval | Olanzapine Orally Disintegrating Tablets, Torrent Pharmaceuticals Ltd., Approval | Olanzapine Orally Disintegrating Tablets, Dr. Reddy's Laboratories Ltd., Approval | Olanzapine, olanzapine, Tablet, Orally Disintegrating; Oral, Barr Labs Inc, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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