olanzapine Disintegrating Oral Tablet

Brand(s)
Zyprexa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-07-23)
Oldest Current Product
2000-06-01
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\OLANZAPINE
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\OLANZAPINE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\OLANZAPINE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\OLANZAPINE

product(s) by strength(s)

olanzapine 10 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000024454ZyprexaNDAEli Lilly And Company2000-06-01OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGNDA021086d5051fbc-846b-4946-82df-341fb1216341

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935246ANDATeva Pharmaceuticals Usa Inc2012-02-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA077243dd0b2525-4e2f-44fc-9302-0ae4ebb1e135
2003785511ANDAMylan Pharmaceuticals Inc.2014-05-12OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20228535b52ceb-5c07-49c5-9b1d-4708db66eaff
3333420084ANDAMacleods Pharmaceuticals Limited2015-02-27OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA203044df43938a-3469-40eb-8166-f0a2fd29d6d8
4498840321ANDAPar Pharmaceutical Companies, Inc.2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA078109d974d2a4-fc65-42ff-8138-cfcfd7381534
5551110263ANDADr. Reddy'S Laboratories Ltd2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA076534aff02cff-d079-bc82-6182-a24c4c6e09a6
6597460307ANDAJubilant Cadista Pharmaceuticals, Inc.2012-09-13OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA200221028aa88e-fa50-7aa8-cc0b-97c0c9a0357c
7605053276ANDAApotex Corp2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA09126596165590-b287-0ed9-3723-752af59aedad
8627560754ANDASun Pharmaceutical Industries Limited2012-02-28OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0908817f243027-7047-47c4-8b66-288c60ec2008
9658620657ANDAAurobindo Pharma Limited2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA2037084d768cfe-3b20-4127-95b9-b4151b28afcc
10669930467ANDAPrasco Laboratories2011-10-25OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0914155f3a9abd-aaca-48b9-8cc9-79bb21179ff5
11669930687ANDAPrasco Laboratories2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20370813adf724-aa00-46bf-a631-530db21f1683

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680616ANDAAvpak2014-04-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATING136680088ANDA09141598697cfd-5521-f8a9-af17-555031690b08
2551541815ZyprexaNDACardinal Health2000-06-01OLANZAPINEORALTABLET, ORALLY DISINTEGRATING000024454NDA0210867881c39e-0624-4c14-a6c3-7a9dc81c198c
3551548299ANDACardinal Health2012-02-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATING000935246ANDA07724316c999a9-399c-4407-883e-8e66b0239ed2

olanzapine 15 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000024455ZyprexaNDAEli Lilly And Company2001-09-01OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGNDA021086d5051fbc-846b-4946-82df-341fb1216341

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935247ANDATeva Pharmaceuticals Usa Inc2012-01-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA077243dd0b2525-4e2f-44fc-9302-0ae4ebb1e135
2003785512ANDAMylan Pharmaceuticals Inc.2014-05-12OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20228535b52ceb-5c07-49c5-9b1d-4708db66eaff
3333420085ANDAMacleods Pharmaceuticals Limited2015-02-27OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA203044df43938a-3469-40eb-8166-f0a2fd29d6d8
4498840322ANDAPar Pharmaceutical Companies, Inc.2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA078109d974d2a4-fc65-42ff-8138-cfcfd7381534
5551110264ANDADr. Reddy'S Laboratories Ltd2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA076534aff02cff-d079-bc82-6182-a24c4c6e09a6
6597460308ANDAJubilant Cadista Pharmaceuticals, Inc.2012-09-13OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA200221028aa88e-fa50-7aa8-cc0b-97c0c9a0357c
7605053277ANDAApotex Corp2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA09126596165590-b287-0ed9-3723-752af59aedad
8627560755ANDASun Pharmaceutical Industries Limited2012-02-28OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0908817f243027-7047-47c4-8b66-288c60ec2008
9658620658ANDAAurobindo Pharma Limited2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA2037084d768cfe-3b20-4127-95b9-b4151b28afcc
10669930468ANDAPrasco Laboratories2011-10-25OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0914155f3a9abd-aaca-48b9-8cc9-79bb21179ff5
11669930688ANDAPrasco Laboratories2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20370813adf724-aa00-46bf-a631-530db21f1683

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680617ANDAAvpak2014-04-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATING136680089ANDA09141598697cfd-5521-f8a9-af17-555031690b08

olanzapine 20 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000024456ZyprexaNDAEli Lilly And Company2001-09-01OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGNDA021086d5051fbc-846b-4946-82df-341fb1216341

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935248ANDATeva Pharmaceuticals Usa Inc2012-01-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA077243dd0b2525-4e2f-44fc-9302-0ae4ebb1e135
2003785513ANDAMylan Pharmaceuticals Inc.2014-05-12OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20228535b52ceb-5c07-49c5-9b1d-4708db66eaff
3333420086ANDAMacleods Pharmaceuticals Limited2015-02-27OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA203044df43938a-3469-40eb-8166-f0a2fd29d6d8
4498840323ANDAPar Pharmaceutical Companies, Inc.2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA078109d974d2a4-fc65-42ff-8138-cfcfd7381534
5551110265ANDADr. Reddy'S Laboratories Ltd2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA076534aff02cff-d079-bc82-6182-a24c4c6e09a6
6597460309ANDAJubilant Cadista Pharmaceuticals, Inc.2012-09-13OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA200221028aa88e-fa50-7aa8-cc0b-97c0c9a0357c
7605053278ANDAApotex Corp2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA09126596165590-b287-0ed9-3723-752af59aedad
8627560757ANDASun Pharmaceutical Industries Limited2012-02-28OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0908817f243027-7047-47c4-8b66-288c60ec2008
9658620659ANDAAurobindo Pharma Limited2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA2037084d768cfe-3b20-4127-95b9-b4151b28afcc
10669930469ANDAPrasco Laboratories2011-10-25OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0914155f3a9abd-aaca-48b9-8cc9-79bb21179ff5
11669930689ANDAPrasco Laboratories2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20370813adf724-aa00-46bf-a631-530db21f1683

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680618ANDAAvpak2014-04-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATING136680090ANDA09141598697cfd-5521-f8a9-af17-555031690b08
2617860442ANDARemedyrepack Inc.2015-10-19OLANZAPINEORALTABLET, ORALLY DISINTEGRATING003785513ANDA202285d1ea62f1-ba77-4490-9a8f-9fa072b093f8
3647250265ANDATya Pharmaceuticals2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATING551110265ANDA0765340421e484-b7a3-4896-b1c7-73b23b38ba32
4647250757ANDATya Pharmaceuticals2012-02-28OLANZAPINEORALTABLET, ORALLY DISINTEGRATING627560757ANDA0908810c5218ff-8d89-445d-ac96-b758ec6200f7

olanzapine 5 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000024453ZyprexaNDAEli Lilly And Company2000-06-01OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGNDA021086d5051fbc-846b-4946-82df-341fb1216341

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935245ANDATeva Pharmaceuticals Usa Inc2012-02-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA077243dd0b2525-4e2f-44fc-9302-0ae4ebb1e135
2003785510ANDAMylan Pharmaceuticals Inc.2014-05-12OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20228535b52ceb-5c07-49c5-9b1d-4708db66eaff
3333420083ANDAMacleods Pharmaceuticals Limited2015-02-27OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA203044df43938a-3469-40eb-8166-f0a2fd29d6d8
4498840320ANDAPar Pharmaceutical Companies, Inc.2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA078109d974d2a4-fc65-42ff-8138-cfcfd7381534
5551110262ANDADr. Reddy'S Laboratories Ltd2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA076534aff02cff-d079-bc82-6182-a24c4c6e09a6
6597460306ANDAJubilant Cadista Pharmaceuticals, Inc.2012-09-13OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA200221028aa88e-fa50-7aa8-cc0b-97c0c9a0357c
7605053275ANDAApotex Corp2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA09126596165590-b287-0ed9-3723-752af59aedad
8627560751ANDASun Pharmaceutical Industries Limited2012-02-28OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0908817f243027-7047-47c4-8b66-288c60ec2008
9658620656ANDAAurobindo Pharma Limited2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA2037084d768cfe-3b20-4127-95b9-b4151b28afcc
10669930466ANDAPrasco Laboratories2011-10-25OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA0914155f3a9abd-aaca-48b9-8cc9-79bb21179ff5
11669930686ANDAPrasco Laboratories2014-05-15OLANZAPINEORALTABLET, ORALLY DISINTEGRATINGANDA20370813adf724-aa00-46bf-a631-530db21f1683

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680615ANDAAvpak2014-04-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATING136680086ANDA09141598697cfd-5521-f8a9-af17-555031690b08
2551541817ZyprexaNDACardinal Health2000-06-01OLANZAPINEORALTABLET, ORALLY DISINTEGRATING000024453NDA0210867881c39e-0624-4c14-a6c3-7a9dc81c198c
3551546672ANDACardinal Health2011-10-24OLANZAPINEORALTABLET, ORALLY DISINTEGRATING605053275ANDA0912652996290f-db34-43eb-b627-573e23f61f7e
4551548298ANDACardinal Health2012-02-17OLANZAPINEORALTABLET, ORALLY DISINTEGRATING000935245ANDA07724316c999a9-399c-4407-883e-8e66b0239ed2
5647250751ANDATya Pharmaceuticals2012-02-28OLANZAPINEORALTABLET, ORALLY DISINTEGRATING627560751ANDA0908810c5218ff-8d89-445d-ac96-b758ec6200f7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA076534OLANZAPINEDR REDDYS LABORATORIES LTD2011-10-24ANDA076534_001, ANDA076534_002, ANDA076534_003, ANDA076534_004
2ANDA077243OLANZAPINEBARR LABORATORIES INC2012-01-30ANDA077243_001, ANDA077243_002, ANDA077243_003, ANDA077243_004
3ANDA078109OLANZAPINEPAR PHARMACEUTICAL INC2011-10-24ANDA078109_001, ANDA078109_002, ANDA078109_003, ANDA078109_004
4ANDA090881OLANZAPINESUN PHARMACEUTICAL INDUSTRIES LTD2012-02-28ANDA090881_001, ANDA090881_002, ANDA090881_003, ANDA090881_004
5ANDA091265OLANZAPINEAPOTEX INC2011-10-24ANDA091265_001, ANDA091265_002, ANDA091265_003, ANDA091265_004
6ANDA091415OLANZAPINETORRENT PHARMACEUTICALS LLC2011-10-25ANDA091415_001, ANDA091415_002, ANDA091415_003, ANDA091415_004
7ANDA200221OLANZAPINEJUBILANT GENERICS LTD2012-09-12ANDA200221_001, ANDA200221_002, ANDA200221_003, ANDA200221_004
8ANDA202285OLANZAPINEMYLAN PHARMACEUTICALS INC2014-05-12ANDA202285_001, ANDA202285_002, ANDA202285_003, ANDA202285_004
9ANDA202937OLANZAPINEORCHID HEALTHCARE2015-03-02ANDA202937_001, ANDA202937_002, ANDA202937_003, ANDA202937_004
10ANDA203044OLANZAPINEMACLEODS PHARMACEUTICALS LTD2015-02-20ANDA203044_001, ANDA203044_002, ANDA203044_003, ANDA203044_004
11ANDA203708OLANZAPINEAUROBINDO PHARMA LTD2014-05-15ANDA203708_001, ANDA203708_002, ANDA203708_003, ANDA203708_004
12NDA021086ZYPREXA ZYDISELI LILLY AND CO2000-04-06p6960577, ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTSNEW PATIENT POPULATION [2016-07-26]NDA021086_001, NDA021086_002, NDA021086_003, NDA021086_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076534_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
2ANDA076534_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
3ANDA076534_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
4ANDA076534_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
5ANDA077243_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-01-30OLANZAPINE
6ANDA077243_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-01-30OLANZAPINE
7ANDA077243_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-01-30OLANZAPINE
8ANDA077243_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-01-30OLANZAPINE
9ANDA078109_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
10ANDA078109_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
11ANDA078109_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
12ANDA078109_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
13ANDA090881_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-02-28OLANZAPINE
14ANDA090881_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-02-28OLANZAPINE
15ANDA090881_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-02-28OLANZAPINE
16ANDA090881_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-02-28OLANZAPINE
17ANDA091265_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
18ANDA091265_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
19ANDA091265_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
20ANDA091265_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-24OLANZAPINE
21ANDA091415_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-25OLANZAPINE
22ANDA091415_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-25OLANZAPINE
23ANDA091415_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-25OLANZAPINE
24ANDA091415_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-10-25OLANZAPINE
25ANDA200221_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-09-12OLANZAPINE
26ANDA200221_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-09-12OLANZAPINE
27ANDA200221_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-09-12OLANZAPINE
28ANDA200221_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-09-12OLANZAPINE
29ANDA202285_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-12OLANZAPINE
30ANDA202285_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-12OLANZAPINE
31ANDA202285_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-12OLANZAPINE
32ANDA202285_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-12OLANZAPINE
33ANDA202937_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-03-02OLANZAPINE
34ANDA202937_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-03-02OLANZAPINE
35ANDA202937_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-03-02OLANZAPINE
36ANDA202937_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-03-02OLANZAPINE
37ANDA203044_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-02-20OLANZAPINE
38ANDA203044_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-02-20OLANZAPINE
39ANDA203044_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-02-20OLANZAPINE
40ANDA203044_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-02-20OLANZAPINE
41ANDA203708_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-15OLANZAPINE
42ANDA203708_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-15OLANZAPINE
43ANDA203708_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-15OLANZAPINE
44ANDA203708_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-05-15OLANZAPINE
45NDA021086_001RXOLANZAPINE (5MG)ORALTABLET, ORALLY DISINTEGRATINGTrueAB2000-04-06ZYPREXA ZYDIS
46NDA021086_002RXOLANZAPINE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2000-04-06ZYPREXA ZYDIS
47NDA021086_003RXOLANZAPINE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2000-04-06ZYPREXA ZYDIS
48NDA021086_004RXOLANZAPINE (20MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2000-04-06ZYPREXA ZYDIS

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6960577 (view patent)2017-11-01NDA021086, NDA018936, NDA020592, NDA021520olanzapine Oral Tablet
Fluoxetine Oral Tablet
Fluoxetine / olanzapine Oral Capsule
Fluoxetine Oral Capsule

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1028aa88e-fa50-7aa8-cc0b-97c0c9a0357c (view SPL)These highlights do not include all the information needed to use olanzapine orally disintegrating tablets, USPsafely and effectively. See full prescribing information for olanzapine orally disintegrating tablets, USP. Olanzapine Orally Disintegrating Tablets, USPfor Oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2015-10-017597460306, 597460307, 597460308, 597460309
20421e484-b7a3-4896-b1c7-73b23b38ba32 (view SPL)These highlights do not include all the information needed to use olanzapine orally disintegrating tablets safely and effectively. See full prescribing information for olanzapine orally disintegrating tablets. Olanzapine Orally Disintegrating Tablets for Oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2013-10-302647250265
30c5218ff-8d89-445d-ac96-b758ec6200f7 (view SPL)These highlights do not include all the information needed to use olanzapine safely and effectively. See full prescribing information for olanzapine orally disintegrating tablets. Olanzapine Orally Disintegrating Tablets, for Oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2012-02-284647250751, 647250757
413adf724-aa00-46bf-a631-530db21f1683 (view SPL)These highlights do not include all the information needed to use olanzapine orally disintegrating tablets safely and effectively. See full prescribing information for olanzapine orally disintegrating tablets. OLANZAPINE orally disintegrating tablets, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionPrasco Laboratories2015-06-171669930686, 669930687, 669930688, 669930689
516c999a9-399c-4407-883e-8e66b0239ed2 (view SPL)These highlights do not include all the information needed to use olanzapine orally disintegrating tablets safely and effectively. See full prescribing information for olanzapine orally disintegrating tablets. Olanzapine Tablets, Orally Disintegrating for Oral UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionCardinal HealthREPACK2013-05-222551548298, 551548299
62996290f-db34-43eb-b627-573e23f61f7e (view SPL)These highlights do not include all the information needed to use Olanzapine Orally Disintegrating Tablets safely and effectively. See full prescribing information for Olanzapine Orally Disintegrating Tablets. Olanzapine Tablet, Orally Disintegrating for Oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionCardinal HealthREPACK2015-04-201551546672
735b52ceb-5c07-49c5-9b1d-4708db66eaff (view SPL)These highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS.OLANZAPINE orally disintegrating tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-207003785510, 003785511, 003785512, 003785513
84d768cfe-3b20-4127-95b9-b4151b28afcc (view SPL)These highlights do not include all the information needed to useOLANZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS. OLANZAPINE orally disintegrating tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-08-043658620656, 658620657, 658620658, 658620659
95f3a9abd-aaca-48b9-8cc9-79bb21179ff5 (view SPL)These highlights do not include all the information needed to use olanzapine safely and effectively. See full prescribing information for olanzapine. Olanzapine Tablets USP, for Oral use Olanzapine Orally Disintegrating Tablets, USPfor Oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionPrasco Laboratories2014-10-143669930466, 669930467, 669930468, 669930469, 669930460, 669930461, 669930462, 669930463, 669930464, 669930465olanzapine Oral Tablet
107881c39e-0624-4c14-a6c3-7a9dc81c198c (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 PrescriptionCardinal HealthREPACK2012-05-082551541815, 551541817, 551541813, 551541814, 551541828olanzapine Oral Tablet
117f243027-7047-47c4-8b66-288c60ec2008 (view SPL)These highlights do not include all the information needed to use OLANZAPINE safely and effectively. See full prescribing information for OLANZAPINE.OLANZAPINE tablets, for oral useOLANZAPINE orally disintegrating tablets, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-09-148627560751, 627560754, 627560755, 627560757, 627560551, 627560552, 627560553, 627560554, 627560555, 627560556olanzapine Oral Tablet
1296165590-b287-0ed9-3723-752af59aedad (view SPL)These highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS, USP . OLANZAPINE tablet, orally disintegrating for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionApotex Corp2015-08-276605053275, 605053276, 605053277, 605053278
1398697cfd-5521-f8a9-af17-555031690b08 (view SPL)These highlights do not include all the information needed to use olanzapine safely and effectively. See full prescribing information for olanzapine. Olanzapine Tablets, USP Olanzapine Orally Disintegrating Tablets Initial U.S. Approval: 1996prescriptionHuman PrescriptionAvpak2014-10-154502680615, 502680616, 502680617, 502680618
14aff02cff-d079-bc82-6182-a24c4c6e09a6 (view SPL)These highlights do not include all the information needed to use olanzapine orally disintegrating tablets safely and effectively. See full prescribing information for olanzapine orally disintegrating tablets. OLANZAPINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-08-1811551110262, 551110263, 551110264, 551110265
15d1ea62f1-ba77-4490-9a8f-9fa072b093f8 (view SPL)These highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS.OLANZAPINE orally disintegrating tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionRemedyrepack Inc.2015-10-191617860442
16d5051fbc-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 Company2015-07-2345000024453, 000024454, 000024455, 000024456, 000024112, 000024115, 000024116, 000024117, 000024415, 000024420, 000027597olanzapine Oral Tablet
olanzapine Injection
17d974d2a4-fc65-42ff-8138-cfcfd7381534 (view SPL)These highlights do not include all the information needed to use Olanzapine Orally Disintegrating Tablets safely and effectively. See full prescribing information for Olanzapine Orally Disintegrating Tablets. Initial U.S. Approval: 1996prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2012-08-313498840320, 498840321, 498840322, 498840323
18dd0b2525-4e2f-44fc-9302-0ae4ebb1e135 (view SPL)These highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS USP safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS USP. OLANZAPINE TABLETS, Orally Disintegrating for Oral UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-036000935245, 000935246, 000935247, 000935248
19df43938a-3469-40eb-8166-f0a2fd29d6d8 (view SPL)These highlights do not include all the information needed to use olanzapine safely and effectively. See full prescribing information for Olanzapine Orally Disintegrating Tablets, USPOLANZAPINE Orally Disintegrating Tablets, USP for Oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-08-273333420083, 333420084, 333420085, 333420086

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