Application 090331

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANSOPRAZOLE	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	No	No
002	LANSOPRAZOLE	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090331-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2010-04-23
A090331-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL			2010-04-23

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 3 · 86 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	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL		2010-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090331-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090331-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-04-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090331-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090331-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090331-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090331-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090331-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090331-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090331-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090331-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090331-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090331-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090331-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090331-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090331-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090331-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090331-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090331-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090331-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090331-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090331-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090331-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090331-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090331-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090331-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090331-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090331-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090331-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090331-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090331-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090331-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090331-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090331-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090331-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090331-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090331-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090331-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090331-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090331-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090331-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090331-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090331-002	AB	1	`1c564ffb4f44…`

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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	44f07613-35be-4673-98f0-4b2467acce9c	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	1dc026b6-b521-4a46-9a74-8c1c140d5329	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd	2023-11-28	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	495d3ca8-d37d-440a-80ce-9342d9ff281a	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	a612a237-ec17-49f0-8985-44407608adb5	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
foster and thrive acid reducer	LANSOPRAZOLE	Strategic Sourcing Services LLC	d02e2f93-3358-4682-b491-0a83889af8a1	2023-09-14	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NorthStar Rx LLC	4c7cc078-09de-f4fc-d111-1248f2261d17	2023-07-15	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	8bbc3af5-faa1-4af1-94e9-9df4aae242ab	2023-06-22	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	33fc642c-ad41-410b-9a81-eae456f3fcfb	2023-04-18	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	551ae468-1a2d-43d6-a2a8-4e5f26e0f982	2023-04-06	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	5ab07bf7-140a-4ca0-9b3a-38da7aa454db	2022-12-13	Warnings	Name fallback generic name: LANSOPRAZOLE
equate lansoprazole	LANSOPRAZOLE	Wal-Mart Stores Inc	89b91d5f-008c-4e9d-83e0-23b673b9c469	2022-12-07	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Proficient Rx LP	3e3e63df-e2ad-420b-acb9-28e65ea6fb07	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals USA Inc.	9b3869ad-f2f7-4954-b75c-5c23b8951635	2022-08-22	Warnings, Adverse reactions	Name fallback brand name: LANSOPRAZOLE generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	BluePoint Laboratories	924c5a35-4804-4e14-a2fc-2b84d186d257	2022-06-20	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Teva Pharmaceuticals USA, Inc.	6b8dd0e1-cd69-4f9a-887f-e42627b5d78e	2022-04-29	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Xiromed LLC	00a574e0-bd03-deea-9f85-b108f78982ba	2022-04-15	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Lifestar Pharma LLC.	afcc0f14-8b00-41ac-8e62-4094a15b959c	2022-03-28	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Dr.Reddy's Laboratories Ltd.	82174fcc-1b0f-2068-7fc4-db335b43b5e2	2022-03-21	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Teva Pharmaceuticals USA, Inc.	427cf924-be17-47dc-8f77-115fa2f3fe17	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2147	Lansoprazole	Lansoprazole	Sandoz Inc	ANDA	Current
0781-2147	Lansoprazole	Lansoprazole	Sandoz Inc	ANDA	Current
0781-2147	Lansoprazole	Lansoprazole	Sandoz Inc	ANDA	Current
0781-2148	Lansoprazole	Lansoprazole	Sandoz Inc	ANDA	Current
0781-2148	Lansoprazole	Lansoprazole	Sandoz Inc	ANDA	Current
0781-2148	Lansoprazole	Lansoprazole	Sandoz Inc	ANDA	Current
68788-6389	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8915	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals Inc.	ANDA	Current