Application 204319

Type: ANDA
Sponsor: QILU

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 1.

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
A204319-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27
A204319-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27
A204319-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27
A204319-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27
A204319-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27
A204319-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204319-001	AB
A204319-002	AB
A204319-003	AB
A204319-004	AB
A204319-005	AB
A204319-006	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 · 246 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
2026-02-19 14:30 UTC	2026-02	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2016-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2016-01-27	`2680178bc6a6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204319-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204319-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204319-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204319-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204319-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204319-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204319-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204319-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204319-004	AB	1	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Upsher-Smith Laboratories, LLC	dbe23f33-9e7d-49a7-8528-fa290661a96f	2025-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204319 application number: ANDA204319
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	6077f5c4-01d7-4c1d-97a0-cb859f98ce68	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204319 application number: ANDA204319 ndc (product): 67184-0565 ndc (product): 67184-0566 ndc (product): 67184-0562 ndc (product): 67184-0561 ndc (product): 67184-0564 ndc (product): 67184-0563

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3933	Olanzapine	Olanzapine	A-S Medication Solutions	ANDA	Current
50090-3934	Olanzapine	Olanzapine	A-S Medication Solutions	ANDA	Current
50090-4040	Olanzapine	Olanzapine	A-S Medication Solutions	ANDA	Current
53002-2505	Olanzapine	Olanzapine	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-665	Olanzapine	Olanzapine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-743	Olanzapine	Olanzapine	Quality Care Products, LLC	ANDA	Current
55700-743	Olanzapine	Olanzapine	Quality Care Products, LLC	ANDA	Current
58118-0381	Olanzapine	Olanzapine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0381	Olanzapine	Olanzapine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0381	Olanzapine	Olanzapine	Clinical Solutions Wholesale, LLC	ANDA	Current
63629-7902	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
63629-7902	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
63629-7902	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
67184-0561	Olanzapine	Olanzapine	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0562	Olanzapine	Olanzapine	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0563	Olanzapine	Olanzapine	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0564	Olanzapine	Olanzapine	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0565	Olanzapine	Olanzapine	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0566	Olanzapine	Olanzapine	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
69543-380	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-380	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-380	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-380	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-381	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-381	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-381	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-381	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-382	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-382	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-382	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-382	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-383	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-383	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-383	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-383	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-384	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-384	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-384	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-384	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-385	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-385	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-385	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-385	Olanzapine	Olanzapine	Virtus Pharmaceuticals, LLC	ANDA	Current
70518-2299	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2299	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2299	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2623	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2623	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2623	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-3189	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-3447	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
71335-1168	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1168	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1168	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1168	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1363	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1363	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1363	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current