Application 090459

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET;ORAL2.5MGNoNo
002OLANZAPINEOLANZAPINETABLET;ORAL5MGNoNo
003OLANZAPINEOLANZAPINETABLET;ORAL7.5MGNoNo
004OLANZAPINEOLANZAPINETABLET;ORAL10MGNoNo
005OLANZAPINEOLANZAPINETABLET;ORAL15MGNoNo
006OLANZAPINEOLANZAPINETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090459-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2018-07-16
A090459-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2018-07-16
A090459-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2018-07-16
A090459-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2018-07-16
A090459-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2018-07-16
A090459-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090459-001AB
A090459-002AB
A090459-003AB
A090459-004AB
A090459-005AB
A090459-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-005OLANZAPINE15MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-006OLANZAPINE20MGTABLET / ORALAB2018-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-001OLANZAPINE2.5MGTABLET / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-002OLANZAPINE5MGTABLET / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-003OLANZAPINE7.5MGTABLET / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-004OLANZAPINE10MGTABLET / ORALAB2018-07-16b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090459-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A090459-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A090459-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090459-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090459-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090459-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090459-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090459-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090459-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090459-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090459-004AB1b8a1b40f171c…

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 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55668be2-62ac-3252-e063-6394a90a40f72026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.e830f488-c689-40f6-9351-f9c7454ff1ea2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINERedpharm Drug54adae9e-6781-6a77-e063-6394a90ab5c82026-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC549dc142-adcd-99ed-e063-6294a90a37fa2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC53e6b4e9-de26-16c3-e063-6294a90a77642026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.032e589c-47b1-4eb1-9466-8160297b81e92026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEAurobindo Pharma Limited4d768cfe-3b20-4127-95b9-b4151b28afcc2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC52bdaaaf-ab54-99d1-e063-6394a90a521f2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEBryant Ranch Prepack4e90e30c-78a1-486f-a13c-f1ff798216be2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC51b508ff-dc55-ff36-e063-6294a90a900f2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC51b64b6d-4676-a637-e063-6394a90a450c2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECoupler LLC518a9400-edb8-6403-e063-6294a90a065d2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OLANZAPINEOLANZAPINEGLENMARK PHARMACEUTICALS INC., USA2e709eaf-4116-4ee3-8dff-ace36181d1152026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OLANZAPINE
generic name: OLANZAPINE
OlanzapineOLANZAPINEModavar Pharmaceuticals LLCf0943b4e-6bdc-48c1-8ecd-39cf732e16f52026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEXGen Pharmaceuticals DJB, Inc.3aad0f7b-8d0c-a9bf-e063-6394a90a6ae82026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEStrides Pharma Science Limited979c3212-36e8-4287-aace-bef0875188d72026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.76a6ff21-7157-4213-8073-35837a3ac07e2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
Olanzapine IntramuscularOLANZAPINEUBI Pharma Inc.6a279fe1-ed99-4a62-b2c7-831961470fa92026-03-23Boxed 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 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-364olanzapineolanzapineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-364olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-364olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-365olanzapineolanzapineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-365olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-365olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-366olanzapineolanzapineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-366olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-366olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-367olanzapineolanzapineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-367olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-367olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-368olanzapineolanzapineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-368olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-368olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-369olanzapineolanzapineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-369olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-369olanzapineolanzapineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1416olanzapineolanzapineZydus Lifesciences LimitedANDACurrent
70771-1416olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1416olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1416olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1417olanzapineolanzapineZydus Lifesciences LimitedANDACurrent
70771-1417olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1417olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1417olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1418olanzapineolanzapineZydus Lifesciences LimitedANDACurrent
70771-1418olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1418olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1418olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1419olanzapineolanzapineZydus Lifesciences LimitedANDACurrent
70771-1419olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1419olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1419olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1420olanzapineolanzapineZydus Lifesciences LimitedANDACurrent
70771-1420olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1420olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1420olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1421olanzapineolanzapineZydus Lifesciences LimitedANDACurrent
70771-1421olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1421olanzapineolanzapineCadila Healthcare LimitedANDACurrent
70771-1421olanzapineolanzapineCadila Healthcare LimitedANDACurrent