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 1 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINECoupler LLC5af81f87-5582-aa23-e063-6294a90a1ee82026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEHikma Pharmaceuticals USA Inc.63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d12026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.c47ee16f-5a86-49f2-8d85-5f49a6c8d91e2026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.5bded04a-d848-4ac6-b7c3-ff9b9fef3d292026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMajor Pharmaceuticals709d79a1-2742-4629-af43-161be166833a2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.9eb6b0d1-b301-4847-88f5-f8613d550ecc2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.b6f0b2e2-3cbd-4564-8b3e-f811589af2752026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.a4c525da-c2f6-b804-af49-6012959222542026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.ad350abc-a1fc-4be4-b2be-c629121552a02026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.1705bab2-a2f8-4534-b1fc-eb309cd2696b2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINECamber Pharmaceuticals, Inc.c1387008-6dc4-4f1e-ae29-fa7a0f0be6842026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
generic name: OLANZAPINE
olanzapineOLANZAPINEBionpharma Inc.8f485576-a4c4-45d4-816f-2e59fce9f5172026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: olanzapine
generic name: OLANZAPINE
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55669a10-93f3-cfd6-e063-6294a90aa0e62026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Olanzapine
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