Application 090798

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	TABLET;ORAL	2.5MG	No	No
002	OLANZAPINE	OLANZAPINE	TABLET;ORAL	5MG	No	No
003	OLANZAPINE	OLANZAPINE	TABLET;ORAL	7.5MG	No	No
004	OLANZAPINE	OLANZAPINE	TABLET;ORAL	10MG	No	No
005	OLANZAPINE	OLANZAPINE	TABLET;ORAL	15MG	No	No
006	OLANZAPINE	OLANZAPINE	TABLET;ORAL	20MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090798-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23
A090798-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23
A090798-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23
A090798-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23
A090798-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23
A090798-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2012-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2012-04-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090798-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090798-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090798-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090798-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090798-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090798-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090798-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090798-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090798-004	AB	1	`b8a1b40f171c…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	e830f488-c689-40f6-9351-f9c7454ff1ea	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798 ndc (product): 70518-0314
Olanzapine	OLANZAPINE	REMEDYREPACK INC.	032e589c-47b1-4eb1-9466-8160297b81e9	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798 ndc (product): 70518-3568
Olanzapine	OLANZAPINE	Golden State Medical Supply, Inc.	a1dfb4e7-4143-4422-b7a7-292e4fd75044	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Apotex Corp.	3347d1c8-04c9-5ce1-8cda-b38e0412b709	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Bryant Ranch Prepack	1866a03c-eac9-44a1-8f33-7dc6e8a8c06a	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	024e8e9b-a4fc-4882-b080-c070467166a6	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Proficient Rx LP	e40d54bf-7334-4418-8a87-ff85941adec1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798
Olanzapine	OLANZAPINE	Aphena Pharma Solutions - Tennessee, LLC	b6ec5610-b4a6-4646-954a-0fe8b1d3e143	2020-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798 ndc (product): 71610-419
Olanzapine	OLANZAPINE	Proficient Rx LP	7772a4c2-1fb1-412b-9e3b-ef3d693517a2	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090798 application number: ANDA090798

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 2 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0314	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0314	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1115	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1115	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1115	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1115	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1115	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-1115	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2079	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2079	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2079	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-3568	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-3568	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
71610-419	Olanzapine	Olanzapine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31496	ORIG	2012-04-25