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 1.

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 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078109-001	OLANZAPINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078109-002	OLANZAPINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078109-003	OLANZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078109-004	OLANZAPINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-10-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078109-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078109-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078109-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078109-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078109-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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