olanzapine Injection

Brand(s)
Zyprexa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-09-04)
Oldest Current Product
2004-04-01
License(s)
NDA, ANDA
RxNORM
INJECTION\OLANZAPINE
FDAOB
INTRAMUSCULAR\INJECTION\OLANZAPINE
INTRAMUSCULAR\SUSPENSION, EXTENDED RELEASE\OLANZAPINE PAMOATE
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\OLANZAPINE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OLANZAPINE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\OLANZAPINE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OLANZAPINE

product(s) by strength(s)

olanzapine 10 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000027597ZyprexaNDAEli Lilly And Company2004-04-01OLANZAPINEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA021253d5051fbc-846b-4946-82df-341fb1216341

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170955ANDAAmerican Regent, Inc.2012-06-27OLANZAPINEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA201741e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee
2007813159ANDASandoz Inc2011-10-24OLANZAPINEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA2015881e9666ef-4271-4834-8496-ccb3125d83db

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1647250955ANDATya Pharmaceuticals2012-06-27OLANZAPINEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION005170955ANDA201741591f9bb1-f119-4739-87b0-de29c9446727
2647253159ANDATya Pharmaceuticals2011-10-24OLANZAPINEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTION007813159ANDA2015883b3bc948-161e-49ee-b67f-4bbb63af23d6

olanzapine 210 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1000027635ZyprexaNDAEli Lilly And Company2010-03-01NDA022173f9a73185-88de-4d7b-b3c0-bbf231483241

olanzapine 300 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1000027636ZyprexaNDAEli Lilly And Company2010-03-01NDA022173f9a73185-88de-4d7b-b3c0-bbf231483241

olanzapine 405 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1000027637ZyprexaNDAEli Lilly And Company2010-03-01NDA022173f9a73185-88de-4d7b-b3c0-bbf231483241

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA201588OLANZAPINESANDOZ INC2011-10-24ANDA201588_001
2ANDA201741OLANZAPINELUITPOLD PHARMACEUTICALS INC2012-03-20ANDA201741_001
3NDA021253ZYPREXAELI LILLY AND CO2004-03-29NDA021253_001
4NDA022173ZYPREXA RELPREVVELI LILLY CO2009-12-11p6169084, A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS., SUBSTANCENDA022173_001, NDA022173_002, NDA022173_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201588_001RXOLANZAPINE (10MG/VIAL)INTRAMUSCULARINJECTIONFalseAP2011-10-24OLANZAPINE
2ANDA201741_001RXOLANZAPINE (10MG/VIAL)INTRAMUSCULARINJECTIONFalseAP2012-03-20OLANZAPINE
3NDA021253_001RXOLANZAPINE (10MG/VIAL)INTRAMUSCULARINJECTIONTrueAP2004-03-29ZYPREXA
4NDA022173_001RXOLANZAPINE PAMOATE (EQ 210MG BASE/VIAL)INTRAMUSCULARSUSPENSION, EXTENDED RELEASEFalse2009-12-11ZYPREXA RELPREVV
5NDA022173_002RXOLANZAPINE PAMOATE (EQ 300MG BASE/VIAL)INTRAMUSCULARSUSPENSION, EXTENDED RELEASEFalse2009-12-11ZYPREXA RELPREVV
6NDA022173_003RXOLANZAPINE PAMOATE (EQ 405MG BASE/VIAL)INTRAMUSCULARSUSPENSION, EXTENDED RELEASETrue2009-12-11ZYPREXA RELPREVV

patent(s)

#idexpiration dateapplication(s)
1p6169084 (view patent)2018-09-30NDA022173

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11e9666ef-4271-4834-8496-ccb3125d83db (view SPL)These highlights do not include all the information needed to use olanzapine for injection safely and effectively. See full prescribing information for olanzapine for injection. OLANZAPINE for injection, powder, for solution for intramuscular useInitial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2015-07-304007813159
23b3bc948-161e-49ee-b67f-4bbb63af23d6 (view SPL)These highlights do not include all the information needed to use Olanzapine for Injection safely and effectively. See full prescribing information for Olanzapine for Injection. Olanzapine for Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 1996prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-11-022647253159
3591f9bb1-f119-4739-87b0-de29c9446727 (view SPL)These highlights do not include all the information needed to use Olanzapine safely and effectively. See full prescribing information for Olanzapine. Olanzapine (Olanzapine) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAMUSCULAR use. Initial U.S. Approval: 2012prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2012-07-052647250955
4d5051fbc-846b-4946-82df-341fb1216341 (view SPL)These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 1996prescriptionHuman PrescriptionEli Lilly And Company2015-07-2345000027597, 000024112, 000024115, 000024116, 000024117, 000024415, 000024420, 000024453, 000024454, 000024455, 000024456olanzapine Oral Tablet
olanzapine Disintegrating Oral Tablet
5e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee (view SPL)These highlights do not include all the information needed to use Olanzapine safely and effectively. See full prescribing information for Olanzapine. Olanzapine (Olanzapine) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAMUSCULAR use.Initial U.S. Approval: 2012prescriptionHuman PrescriptionAmerican Regent, Inc.2012-07-054005170955
6f9a73185-88de-4d7b-b3c0-bbf231483241 (view SPL)These highlights do not include all the information needed to use ZYPREXA RELPREVV safely and effectively. See full prescribing information for ZYPREXA RELPREVV.ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable SuspensionInitial U.S. Approval: 1996prescriptionHuman PrescriptionEli Lilly And Company2015-09-0445000027635, 000027636, 000027637

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII