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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Proficient Rx LP	7d811f01-f0c2-4753-bb36-80b48dabb58c	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Camber Pharmaceuticals, Inc.	03b7dceb-2128-4324-b068-7f76a2d9887e	2020-06-30	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
equate lansoprazole delayed release	LANSOPRAZOLE	Wal-Mart Stores Inc	3eb7a657-625a-46bf-a196-4ba6aa41a7bf	2020-05-06	Warnings	Name fallback generic name: LANSOPRAZOLE
lansoprazole	LANSOPRAZOLE	Publix Super Markets Inc	e226a1eb-39c8-440a-9824-1e5ccddc249e	2020-04-14	Warnings	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