Application 078109

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	No	No
002	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
003	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No
004	OLANZAPINE	OLANZAPINE	TABLET, ORALLY DISINTEGRATING;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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078109-001	OLANZAPINE	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A078109-002	OLANZAPINE	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A078109-003	OLANZAPINE	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24
A078109-004	OLANZAPINE	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078109-001	AB
A078109-002	AB
A078109-003	AB
A078109-004	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 5 · 172 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	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A078109-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078109-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078109-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078109-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078109-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078109-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078109-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078109-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078109-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078109-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078109-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078109-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078109-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078109-004	AB	1	`5bbf6a4d5a75…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Strides Pharma Science Limited	979c3212-36e8-4287-aace-bef0875188d7	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078109 application number: ANDA078109 ndc (product): 64380-172 ndc (product): 64380-174 ndc (product): 64380-175 ndc (product): 64380-173

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-320	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-320	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-320	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-320	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-320	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-320	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-321	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-321	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-321	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-321	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-321	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-321	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-322	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-322	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-322	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-322	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-322	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-322	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-323	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-323	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-323	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-323	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-323	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
49884-323	Olanzapine	olanzapine	Par Pharmaceutical, Inc.	ANDA	Current
50090-3958	Olanzapine	olanzapine	A-S Medication Solutions	ANDA	Current
50090-3958	Olanzapine	olanzapine	A-S Medication Solutions	ANDA	Current
50090-3958	Olanzapine	olanzapine	A-S Medication Solutions	ANDA	Current
50090-3967	Olanzapine	olanzapine	A-S Medication Solutions	ANDA	Current
50090-3967	Olanzapine	olanzapine	A-S Medication Solutions	ANDA	Current
50090-3967	Olanzapine	olanzapine	A-S Medication Solutions	ANDA	Current
63629-2237	Olanzapine	olanzapine	Bryant Ranch Prepack	ANDA	Current
63629-2237	Olanzapine	olanzapine	Bryant Ranch Prepack	ANDA	Current
63629-2237	Olanzapine	olanzapine	Bryant Ranch Prepack	ANDA	Current
64380-172	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-172	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-173	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-173	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-174	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-174	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-175	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current
64380-175	Olanzapine	olanzapine	Strides Pharma Science Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31332	ORIG	2011-10-26