Application 091265

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL5MGNoNo
002OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo
003OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL15MGNoNo
004OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091265-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A091265-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A091265-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A091265-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091265-001AB
A091265-002AB
A091265-003AB
A091265-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091265-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091265-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091265-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091265-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091265-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091265-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091265-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091265-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091265-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091265-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091265-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091265-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091265-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091265-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091265-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091265-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091265-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091265-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091265-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091265-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091265-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091265-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091265-004AB1d06236e962d9…

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINECoupler LLC37c88965-c51d-946d-e063-6394a90a012c2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
OlanzapineOLANZAPINEBryant Ranch Prepackd5a9f78e-56f4-4249-800c-5f52a99fa84b2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
ndc (product): 63629-8714
OlanzapineOLANZAPINEBryant Ranch Prepackd3857220-d9ff-4820-bf53-f2384b59a1a62025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
ndc (product): 63629-8717
OlanzapineOLANZAPINEBryant Ranch Prepacked93d6b9-912a-444a-a695-439d0bfb877a2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
ndc (product): 63629-8718
OlanzapineOLANZAPINEBryant Ranch Prepack58f175a8-5549-4f9e-baf4-8dc340c2cfd52025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
ndc (product): 63629-8719
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.9847a0e4-24fc-f4e8-e053-2995a90a961e2025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
ndc (product): 51407-261
ndc (product): 51407-264
ndc (product): 51407-263
ndc (product): 51407-262
OlanzapineOLANZAPINEApotex Corp.96165590-b287-0ed9-3723-752af59aedad2025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265
ndc (product): 60505-3275
ndc (product): 60505-3278
ndc (product): 60505-3277
ndc (product): 60505-3276
OlanzapineOLANZAPINECoupler LLC325d5d69-5133-79ea-e063-6294a90afdd02025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091265
application number: ANDA091265

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3405OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
63629-8714OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8714OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8714OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8717OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8717OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8717OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8718OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8718OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8718OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8719OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8719OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8719OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
70518-1154OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1154OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1206OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1206OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1207OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1207OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
72789-265OlanzapineOlanzapinePD-Rx Pharmaceuticals, Inc.ANDACurrent