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ZYPREXA ZYDIS (nda021086)- (5MG,10MG,15MG,20MG)

OLANZAPINE CHEPLAPHARM
5MG,10MG,15MG,20MG
Yes No
2017-Nov-01 Expired
None None
None No
ZYPREXA ZYDIS® (olanzapine) is an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder.
14 0 9
Total Other Developers 1
Drugs with Suitability No
5MG ** ** - - 8
10MG ** ** - - 8
15MG ** ** - - 8
20MG ** ** - - 8
NDA Sales Available Total Generic Sales Available
Yes 8
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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