Application 202862

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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
A202862-001	OLANZAPINE	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15
A202862-002	OLANZAPINE	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15
A202862-003	OLANZAPINE	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15
A202862-004	OLANZAPINE	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15
A202862-005	OLANZAPINE	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15
A202862-006	OLANZAPINE	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202862-001	AB
A202862-002	AB
A202862-003	AB
A202862-004	AB
A202862-005	AB
A202862-006	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	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	OLANZAPINE	15MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	OLANZAPINE	20MG	TABLET / ORAL	AB	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	OLANZAPINE	2.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	OLANZAPINE	5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	OLANZAPINE	7.5MG	TABLET / ORAL	AB	2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	OLANZAPINE	10MG	TABLET / ORAL	AB	2014-08-15	`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	A202862-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202862-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202862-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202862-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202862-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202862-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202862-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202862-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202862-004	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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Proficient Rx LP	ce66d545-015b-41d5-80c3-964d78e36bfd	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862 ndc (product): 63187-340
Olanzapine	OLANZAPINE	Proficient Rx LP	1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862 ndc (product): 63187-364
Olanzapine	OLANZAPINE	Proficient Rx LP	61424fa3-b09a-4267-a208-a7c7c3f69fe5	2020-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202862 application number: ANDA202862 ndc (product): 71205-487

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 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8243	Olanzapine	Olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8244	Olanzapine	Olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8245	Olanzapine	Olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8246	Olanzapine	Olanzapine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
33342-067	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-067	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-067	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-067	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-067	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-068	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-068	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-068	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-068	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-068	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-069	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-069	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-069	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-069	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-069	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-070	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-070	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-070	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-070	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-070	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-071	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-071	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-071	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-071	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-071	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-072	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-072	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-072	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-072	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
33342-072	Olanzapine	Olanzapine	Macleods Pharmaceuticals Limited	ANDA	Current
55700-809	Olanzapine	Olanzapine	Quality Care Products, LLC	ANDA	Current
55700-862	Olanzapine	Olanzapine	Quality Care Products, LLC	ANDA	Current
63187-340	Olanzapine	Olanzapine	Proficient Rx LP	ANDA	Current
63187-340	Olanzapine	Olanzapine	Proficient Rx LP	ANDA	Current
63187-364	Olanzapine	Olanzapine	Proficient Rx LP	ANDA	Current
63187-364	Olanzapine	Olanzapine	Proficient Rx LP	ANDA	Current
63187-364	Olanzapine	Olanzapine	Proficient Rx LP	ANDA	Current
63629-8274	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
63629-8274	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
67046-525	Olanzapine	Olanzapine	Contract Pharmacy Services-PA	ANDA	Current
68071-2720	Olanzapine	Olanzapine	NuCare Pharmceuticals,Inc.	ANDA	Current
68788-7161	Olanzapine	Olanzapine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7161	Olanzapine	Olanzapine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7161	Olanzapine	Olanzapine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7161	Olanzapine	Olanzapine	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0921	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0921	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0921	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0935	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-0935	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2337	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2337	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2337	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2375	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2375	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2375	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2698	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2698	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2698	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
70518-2698	Olanzapine	Olanzapine	REMEDYREPACK INC.	ANDA	Current
71205-487	Olanzapine	Olanzapine	Proficient Rx LP	ANDA	Current
71335-0534	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-0534	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-0534	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-0534	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current
71335-1760	Olanzapine	Olanzapine	Bryant Ranch Prepack	ANDA	Current