Application 090798

Type
ANDA
Sponsor
APOTEX INC

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 1.

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
A090798-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2012-04-23
A090798-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2012-04-23
A090798-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2012-04-23
A090798-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2012-04-23
A090798-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2012-04-23
A090798-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2012-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090798-001AB
A090798-002AB
A090798-003AB
A090798-004AB
A090798-005AB
A090798-006AB

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-232680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090798-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090798-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-004AB12680178bc6a6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.e830f488-c689-40f6-9351-f9c7454ff1ea2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
ndc (product): 70518-0314
OlanzapineOLANZAPINEREMEDYREPACK INC.032e589c-47b1-4eb1-9466-8160297b81e92026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
ndc (product): 60429-622
ndc (product): 60429-625
ndc (product): 60429-624
ndc (product): 60429-620
ndc (product): 60429-621
ndc (product): 60429-623
OlanzapineOLANZAPINEApotex Corp.3347d1c8-04c9-5ce1-8cda-b38e0412b7092025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
ndc (product): 60505-3140
ndc (product): 60505-3114
ndc (product): 60505-3112
ndc (product): 60505-3111
ndc (product): 60505-3113
ndc (product): 60505-3110
OlanzapineOLANZAPINEBryant Ranch Prepack1866a03c-eac9-44a1-8f33-7dc6e8a8c06a2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEProficient Rx LP024e8e9b-a4fc-4882-b080-c070467166a62024-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEProficient Rx LPe40d54bf-7334-4418-8a87-ff85941adec12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
ndc (product): 63187-429
ndc (product): 63187-453
OlanzapineOLANZAPINEAphena Pharma Solutions - Tennessee, LLCb6ec5610-b4a6-4646-954a-0fe8b1d3e1432020-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEProficient Rx LP7772a4c2-1fb1-412b-9e3b-ef3d693517a22019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
ndc (product): 63187-844

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-954OlanzapineOlanzapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3081OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50090-3100OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50268-609OlanzapineOlanzapineAvPAKANDACurrent
50268-609OlanzapineOlanzapineAvPAKANDACurrent
50268-610OlanzapineOlanzapineAvPAKANDACurrent
50268-610OlanzapineOlanzapineAvPAKANDACurrent
50268-611OlanzapineOlanzapineAvPAKANDACurrent
50268-611OlanzapineOlanzapineAvPAKANDACurrent
50268-612OlanzapineOlanzapineAvPAKANDACurrent
50268-612OlanzapineOlanzapineAvPAKANDACurrent
50268-613OlanzapineOlanzapineAvPAKANDACurrent
50268-613OlanzapineOlanzapineAvPAKANDACurrent
50268-614OlanzapineOlanzapineAvPAKANDACurrent
50268-614OlanzapineOlanzapineAvPAKANDACurrent
53002-1505OlanzapineOlanzapineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1505OlanzapineOlanzapineRPK Pharmaceuticals, Inc.ANDACurrent
55700-571OlanzapineOlanzapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-3111OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
58118-3111OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60505-3110OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3110OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3110OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3111OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3111OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3111OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3112OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3112OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3112OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3113OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3113OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3113OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3114OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3114OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3114OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3140OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3140OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3140OlanzapineOlanzapineApotex Corp.ANDACurrent
63187-429OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-429OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-453OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-453OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-844OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-844OlanzapineOlanzapineProficient Rx LPANDACurrent
67046-522OlanzapineOlanzapineContract Pharmacy Services-PAANDACurrent
67046-523OlanzapineOlanzapineContract Pharmacy Services-PAANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31496ORIG2012-04-25