Fluoxetine / olanzapine Oral Capsule

Brand(s)
Symbyax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-08-06)
Oldest Current Product
2004-01-19
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\FLUOXETINE:OLANZAPINE
FDAOB
ORAL\CAPSULE\FLUOXETINE HYDROCHLORIDE: OLANZAPINE
SPL Active
ORAL\CAPSULE\FLUOXETINE HYDROCHLORIDE: OLANZAPINE
SPL Moiety
ORAL\CAPSULE\FLUOXETINE: OLANZAPINE

product(s) by strength(s)

fluoxetine 25 mg / olanzapine 12 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000023232SymbyaxNDAEli Lilly And Company2004-01-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULENDA0215206b28c424-0b7e-4b75-b090-f116b113554e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935506ANDATeva Pharmaceuticals Usa Inc2012-06-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0775283c28cf18-01a3-468a-ab3e-8aa82f918251
2007812192ANDASandoz Inc2012-11-30FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA078901fad5c029-4531-4913-ab7b-0c68a625447f
3498840252ANDAPar Pharmaceutical Companies, Inc.2012-11-28FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0777422f6ceda3-3edc-4427-98a6-23e3c930c44d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910655ANDAAvkare, Inc.2014-01-21FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULE000935506ANDA077528f5f78ed2-4640-8528-c51c-d7bffa045d48

fluoxetine 25 mg / olanzapine 3 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000023230SymbyaxNDAEli Lilly And Company2007-04-09FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULENDA0215206b28c424-0b7e-4b75-b090-f116b113554e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935503ANDATeva Pharmaceuticals Usa Inc2013-04-10FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA2020743c28cf18-01a3-468a-ab3e-8aa82f918251
2007812195ANDASandoz Inc2012-11-30FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA078901fad5c029-4531-4913-ab7b-0c68a625447f
3498840277ANDAPar Pharmaceutical Companies, Inc.2012-11-28FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0777422f6ceda3-3edc-4427-98a6-23e3c930c44d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910652ANDAAvkare, Inc.2014-01-21FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULE000935503ANDA202074f5f78ed2-4640-8528-c51c-d7bffa045d48

fluoxetine 25 mg / olanzapine 6 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000023231SymbyaxNDAEli Lilly And Company2004-01-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULENDA0215206b28c424-0b7e-4b75-b090-f116b113554e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935504ANDATeva Pharmaceuticals Usa Inc2012-06-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0775283c28cf18-01a3-468a-ab3e-8aa82f918251
2007812191ANDASandoz Inc2012-11-30FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA078901fad5c029-4531-4913-ab7b-0c68a625447f
3498840250ANDAPar Pharmaceutical Companies, Inc.2012-11-28FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0777422f6ceda3-3edc-4427-98a6-23e3c930c44d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910653ANDAAvkare, Inc.2014-01-21FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULE000935504ANDA077528f5f78ed2-4640-8528-c51c-d7bffa045d48

fluoxetine 50 mg / olanzapine 12 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000023234SymbyaxNDAEli Lilly And Company2004-01-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULENDA0215206b28c424-0b7e-4b75-b090-f116b113554e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935507ANDATeva Pharmaceuticals Usa Inc2012-06-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0775283c28cf18-01a3-468a-ab3e-8aa82f918251
2007812194ANDASandoz Inc2012-11-30FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA078901fad5c029-4531-4913-ab7b-0c68a625447f
3498840253ANDAPar Pharmaceutical Companies, Inc.2012-11-28FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0777422f6ceda3-3edc-4427-98a6-23e3c930c44d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910656ANDAAvkare, Inc.2014-01-21FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULE000935507ANDA077528f5f78ed2-4640-8528-c51c-d7bffa045d48

fluoxetine 50 mg / olanzapine 6 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000023233SymbyaxNDAEli Lilly And Company2004-01-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULENDA0215206b28c424-0b7e-4b75-b090-f116b113554e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935505ANDATeva Pharmaceuticals Usa Inc2012-06-19FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0775283c28cf18-01a3-468a-ab3e-8aa82f918251
2007812193ANDASandoz Inc2012-11-30FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA078901fad5c029-4531-4913-ab7b-0c68a625447f
3498840251ANDAPar Pharmaceutical Companies, Inc.2012-11-28FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULEANDA0777422f6ceda3-3edc-4427-98a6-23e3c930c44d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910654ANDAAvkare, Inc.2014-01-21FLUOXETINE HYDROCHLORIDE, OLANZAPINEORALCAPSULE000935505ANDA077528f5f78ed2-4640-8528-c51c-d7bffa045d48

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA077528OLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA2012-06-19ANDA077528_001, ANDA077528_002, ANDA077528_003, ANDA077528_004
2ANDA077742OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPAR PHARMACEUTICAL INC2012-11-02ANDA077742_001, ANDA077742_002, ANDA077742_003, ANDA077742_004, ANDA077742_005
3ANDA078901OLANZAPINE AND FLUOXETINE HYDROCHLORIDESANDOZ INC2012-11-16ANDA078901_001, ANDA078901_002, ANDA078901_003, ANDA078901_004, ANDA078901_005
4ANDA202074OLANZAPINE AND FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA2013-03-25ANDA202074_001
5NDA021520SYMBYAXELI LILLY AND CO2003-12-24p6960577, SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS
p5945416, SUBSTANCE
ADDITIONS TO THE LABELING DESCRIBING RESULTS FROM STUDY H6P-MC-HDAY [2017-10-10]
NEW PATIENT POPULATION [2016-07-26]
NDA021520_001, NDA021520_002, NDA021520_003, NDA021520_004, NDA021520_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077528_001RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2012-06-19OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
2ANDA077528_002RXOLANZAPINE (EQ 12MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2012-06-19OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
3ANDA077528_003RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULEFalseAB2012-06-19OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
4ANDA077528_004RXOLANZAPINE (EQ 12MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULEFalseAB2012-06-19OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
5ANDA077742_001RXFLUOXETINE HYDROCHLORIDE (EQ 25MG BASE), OLANZAPINE (EQ 3MG BASE)ORALCAPSULEFalseAB2012-11-02OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
6ANDA077742_002RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2012-11-02OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
7ANDA077742_003RXFLUOXETINE HYDROCHLORIDE (EQ 25MG BASE), OLANZAPINE (EQ 12MG BASE)ORALCAPSULEFalseAB2012-11-02OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
8ANDA077742_004RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULEFalseAB2012-11-02OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
9ANDA077742_005RXFLUOXETINE HYDROCHLORIDE (EQ 50MG BASE), OLANZAPINE (EQ 12MG BASE)ORALCAPSULEFalseAB2012-11-02OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
10ANDA078901_001RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2012-11-16OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
11ANDA078901_002RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULEFalseAB2012-11-16OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
12ANDA078901_003RXFLUOXETINE HYDROCHLORIDE (EQ 25MG BASE), OLANZAPINE (EQ 12MG BASE)ORALCAPSULEFalseAB2012-11-16OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
13ANDA078901_004RXOLANZAPINE (EQ 12MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULEFalseAB2012-11-16OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
14ANDA078901_005RXFLUOXETINE HYDROCHLORIDE (EQ 25MG BASE), OLANZAPINE (EQ 3MG BASE)ORALCAPSULEFalseAB2012-11-16OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
15ANDA202074_001RXOLANZAPINE (EQ 3MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2013-03-25OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
16NDA021520_001RXFLUOXETINE HYDROCHLORIDE (EQ 25MG BASE), OLANZAPINE (EQ 3MG BASE)ORALCAPSULEFalseAB2007-04-09SYMBYAX
17NDA021520_002RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2003-12-24SYMBYAX
18NDA021520_003RXOLANZAPINE (EQ 6MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULETrueAB2003-12-24SYMBYAX
19NDA021520_004RXOLANZAPINE (EQ 12MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 25MG BASE)ORALCAPSULEFalseAB2003-12-24SYMBYAX
20NDA021520_005RXOLANZAPINE (EQ 12MG BASE), FLUOXETINE HYDROCHLORIDE (EQ 50MG BASE)ORALCAPSULEFalseAB2003-12-24SYMBYAX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5945416 (view patent)2017-03-24NDA021520
2p6960577 (view patent)2017-11-01NDA021520, NDA018936, NDA020592, NDA021086olanzapine Oral Tablet
Fluoxetine Oral Tablet
olanzapine Disintegrating Oral Tablet
Fluoxetine Oral Capsule

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12f6ceda3-3edc-4427-98a6-23e3c930c44d (view SPL)These highlights do not include all the information needed to use Olanzapine and Fluoxetine Capsules USP safely and effectively. See full prescribing information for Olanzapine and Fluoxetine Capsules USP. Olanzapine and Fluoxetine Capsules USP for oral use.Initial U.S. Approval: 2003prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2013-02-272498840250, 498840251, 498840252, 498840253, 498840277
23c28cf18-01a3-468a-ab3e-8aa82f918251 (view SPL)These highlights do not include all the information needed to use olanzapine and fluoxetine capsules USP safely and effectively. See full prescribing information for olanzapine and fluoxetine capsules USP. OLANZAPINE and FLUOXETINE capsules USP for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-02-037000935503, 000935504, 000935505, 000935506, 000935507
36b28c424-0b7e-4b75-b090-f116b113554e (view SPL)These highlights do not include all the information needed to use SYMBYAX safely and effectively. See full prescribing information for SYMBYAX.SYMBYAX (olanzapine and fluoxetine) capsules for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionEli Lilly And Company2015-08-0659000023230, 000023231, 000023232, 000023233, 000023234
4f5f78ed2-4640-8528-c51c-d7bffa045d48 (view SPL)These highlights do not include all the information needed to use olanzapine and fluoxetine capsules USP safely and effectively. See full prescribing information for olanzapine and fluoxetine capsules USP. OLANZAPINE and FLUOXETINE capsules USP for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionAvkare, Inc.2014-01-212422910652, 422910653, 422910654, 422910655, 422910656
5fad5c029-4531-4913-ab7b-0c68a625447f (view SPL)These highlights do not include all the information needed to use OLANZAPINE and FLUOXETINE CAPSULES, USP safely and effectively. See full prescribing information for OLANZAPINE and FLUOXETINE CAPSULES, USP. OLANZAPINE and FLUOXETINE capsules, for oral use. Initial U.S. Approval: 2003prescriptionHuman PrescriptionSandoz Inc2015-06-2312007812191, 007812192, 007812193, 007812194, 007812195

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