Application 020592

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYPREXAOLANZAPINETABLET;ORAL2.5MGYesNo
002ZYPREXAOLANZAPINETABLET;ORAL5MGYesYes
003ZYPREXAOLANZAPINETABLET;ORAL7.5MGYesNo
004ZYPREXAOLANZAPINETABLET;ORAL10MGYesNo
005ZYPREXAOLANZAPINETABLET;ORAL15MGYesNo
006ZYPREXAOLANZAPINETABLET;ORAL20MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020592-001ZYPREXAOLANZAPINE2.5MGTABLET / ORALABRLD1996-09-30
N020592-002ZYPREXAOLANZAPINE5MGTABLET / ORALABRLD, RS1996-09-30
N020592-003ZYPREXAOLANZAPINE7.5MGTABLET / ORALABRLD1996-09-30
N020592-004ZYPREXAOLANZAPINE10MGTABLET / ORALABRLD1996-09-30
N020592-005ZYPREXAOLANZAPINE15MGTABLET / ORALABRLD1997-09-09
N020592-006ZYPREXAOLANZAPINE20MGTABLET / ORALABRLD1997-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N020592-001AB
N020592-002AB
N020592-003AB
N020592-004AB
N020592-005AB
N020592-006AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30c2088c7a36db…
2026-10-15 13:18:302026-09N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30c2088c7a36db…
2026-10-15 13:18:302026-09N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30c2088c7a36db…
2026-10-15 13:18:302026-09N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30c2088c7a36db…
2026-10-15 13:18:302026-09N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-09c2088c7a36db…
2026-10-15 13:18:302026-09N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-09c2088c7a36db…
2026-09-14 22:38:342026-08N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-3084e616aacf4f…
2026-09-14 22:38:342026-08N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-3084e616aacf4f…
2026-09-14 22:38:342026-08N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-3084e616aacf4f…
2026-09-14 22:38:342026-08N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-3084e616aacf4f…
2026-09-14 22:38:342026-08N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-0984e616aacf4f…
2026-09-14 22:38:342026-08N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-0984e616aacf4f…
2026-08-18 06:07:402026-07N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020592-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020592-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020592-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020592-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020592-005AB1c2088c7a36db…
2026-10-15 13:18:302026-09N020592-006AB1c2088c7a36db…
2026-09-14 22:38:342026-08N020592-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020592-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020592-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020592-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N020592-005AB184e616aacf4f…
2026-09-14 22:38:342026-08N020592-006AB184e616aacf4f…
2026-08-18 06:07:402026-07N020592-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020592-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020592-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020592-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-004AB1fd3edfee7708…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEDirect_Rx22528ae1-e36f-48e1-e063-6294a90a3dd22024-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINENorthStar RxLLCea3259d5-36ee-4ac9-b849-9625626e21872024-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEQilu Pharmaceutical Co., Ltd.6077f5c4-01d7-4c1d-97a0-cb859f98ce682024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP024e8e9b-a4fc-4882-b080-c070467166a62024-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINENorthStar RxLLCf4e41c2c-d32d-40c2-8afb-b6df998ba6b02023-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINELannett Company, Inc.002dd00f-7946-ea4f-e063-6294a90a59162023-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack09e48e71-4dd2-4538-91d7-5b284f6647d82023-03-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LPce66d545-015b-41d5-80c3-964d78e36bfd2023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.9a57a63e-f856-aafa-037a-c08f2fea64962022-10-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP1f4a2eaf-3a12-4ebe-b97f-0a7bfbc325722022-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LPe40d54bf-7334-4418-8a87-ff85941adec12021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP61424fa3-b09a-4267-a208-a7c7c3f69fe52020-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEAphena Pharma Solutions - Tennessee, LLCb6ec5610-b4a6-4646-954a-0fe8b1d3e1432020-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE
OlanzapineOLANZAPINEProficient Rx LP7772a4c2-1fb1-412b-9e3b-ef3d693517a22019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OLANZAPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4112ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4112ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4112ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4112ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4112ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4112ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4115ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4115ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4115ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4115ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4115ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4115ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4116ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4116ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4116ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4116ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4116ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4116ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4117ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4117ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4117ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4117ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4117ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4117ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4415ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4415ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4415ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4415ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4415ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4415ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4420ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4420ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4420ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4420ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4420ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
0002-4420ZyprexaOlanzapineEli Lilly and CompanyNDACurrent
21695-140ZyprexaOlanzapineRebel Distributors CorpNDACurrent
21695-142ZyprexaOlanzapineRebel Distributors CorpNDACurrent
21695-144ZyprexaOlanzapineRebel Distributors CorpNDACurrent
49999-606ZyprexaOlanzapineLake Erie Medical DBA Quality Care Products LLCNDACurrent
52959-579ZyprexaOlanzapineH.J. Harkins Company, Inc.NDACurrent
55289-213ZyprexaOlanzapinePD-Rx Pharmaceuticals, Inc.NDACurrent
68258-7090ZyprexaOlanzapineDispensing Solutions, Inc.NDACurrent
68258-7091ZyprexaOlanzapineDispensing Solutions, Inc.NDACurrent
68258-7092ZyprexaOlanzapineDispensing Solutions, Inc.NDACurrent
68258-7093ZyprexaOlanzapineDispensing Solutions, Inc.NDACurrent
70518-1465ZyprexaOlanzapineREMEDYREPACK INC.NDACurrent
70518-1465ZyprexaOlanzapineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84950SUPPL 2026-02-05
84889SUPPL 2026-02-03
84951SUPPL 2026-01-30
81159SUPPL 2025-02-07
80957SUPPL 2025-02-05
62676SUPPL2020-04-24
62663SUPPL2020-04-24
62662SUPPL2020-04-24
62635SUPPL2020-04-22
62634SUPPL2020-04-22
62629SUPPL2020-04-22
60660SUPPL2019-10-24
60657SUPPL2019-10-24
60635SUPPL2019-10-23
53520SUPPL2018-03-29
53472SUPPL2018-03-28
47377SUPPL2017-03-02
47376SUPPL2017-03-02
47347SUPPL2017-02-27
47346SUPPL2017-02-27
45532SUPPL2016-10-14
45600SUPPL2016-10-07
34914SUPPL2015-07-24
12799SUPPL2015-01-09
2817SUPPL2014-12-23
12800SUPPL2013-07-30
2818SUPPL2013-07-30
41458SUPPL2012-03-16
41457SUPPL2012-03-16
41455SUPPL2012-03-16
20747SUPPL2012-03-16
20749SUPPL2012-01-27
44059ORIG2011-12-22
41456SUPPL2011-06-30
20748SUPPL2011-06-30
34913SUPPL2011-06-29
12798SUPPL2011-06-29
25267SUPPL2011-06-27
25266SUPPL2011-06-27
44452SUPPL2011-01-07
25265SUPPL2010-12-06
12797SUPPL2010-12-04
34912SUPPL2010-06-03
34911SUPPL2010-06-03
25264SUPPL2010-06-03
2816SUPPL2010-06-03
25263SUPPL2010-02-01
34910SUPPL2010-01-29
25260SUPPL2010-01-26
2813SUPPL2010-01-26
12794SUPPL2009-12-10
12793SUPPL2009-12-10
25262SUPPL2009-11-19
34909SUPPL2009-09-17
20746SUPPL2009-09-16
20745SUPPL2009-09-16
34908SUPPL2009-03-20
2815SUPPL2008-08-19
20743ORIG2007-11-19
25261SUPPL2007-07-10
12796SUPPL2007-07-10
12795SUPPL2007-07-10
2814SUPPL2007-07-10
41454SUPPL2007-07-06
20744SUPPL2007-04-11
25259SUPPL2006-12-28
34907SUPPL2006-12-04
2809SUPPL2006-09-18
34905SUPPL2006-08-29
2812SUPPL2006-03-01
34906SUPPL2006-02-28
25258SUPPL2006-02-22
12792SUPPL2006-02-22
12791SUPPL2006-02-22
2810SUPPL2006-02-22
2811SUPPL2005-09-15
25257SUPPL2005-08-08
25256SUPPL2005-06-29
41453SUPPL2004-04-15
12790SUPPL2004-01-22
2808SUPPL2004-01-22
2807SUPPL2003-07-28
34904SUPPL2003-07-10
52115SUPPL1900-01-01
52114SUPPL1900-01-01
52113SUPPL1900-01-01
52111SUPPL1900-01-01
52110SUPPL1900-01-01
52109SUPPL1900-01-01