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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Golden State Medical Supply, Inc.	a9dd7e56-1aee-5f0b-e053-2995a90a43bf	2024-12-23	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Macleods Pharmaceuticals Limited	75691c2d-2265-4153-bc3a-4f7d5d51e250	2024-12-02	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
LANSOPRAZOLE	LANSOPRAZOLE	Zydus Lifesciences Limited	76ffd38e-bea8-45a0-b6bd-82f0043ce64d	2024-11-30		Name fallback brand name: LANSOPRAZOLE generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	22f416bf-00f1-ceb9-e063-6394a90aa1dd	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Mylan Pharmaceuticals Inc.	c8fa7401-907f-41b6-a2e1-f4bc214f2cdf	2024-09-15	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	8f0d3f2f-91d9-467a-a841-540664af80f9	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e07c7445-9652-4833-8b17-45c0124c4e5d	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NorthStar Rx LLC	ac051296-6fe3-4ab5-a001-cc3e06199a22	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	b12cca1c-da28-67e2-e053-2a95a90aaf6b	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Members Mark Lansoprazole	LANSOPRAZOLE	Sam's West Inc	fee84ce3-a884-4944-a32b-72e69a1229d4	2024-07-15	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	9a277b9e-2e13-27c3-e053-2995a90a7ed5	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	91d69826-df5c-47a2-b852-3083629d1893	2024-06-17	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Dr.Reddys Laboratories Inc	656bc92a-1f95-047d-cd27-724073e63fe6	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	6d81faf7-aa59-429c-e053-2a91aa0a8bb2	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Aurobindo Pharma Limited	1f2883d8-12db-40b7-9104-22a6690a22a7	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Mylan Pharmaceuticals Inc.	20ff347c-ca18-497b-948d-1145035f2ffc	2024-03-11	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	136ad992-2e39-dad9-e063-6294a90adcc6	2024-03-11	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	11344047-7ed4-61e7-e063-6394a90a332d	2024-02-12	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e0299cf2-8a8e-499b-a81e-16e844ea3aff	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	ae03d05b-0a0f-4bae-bbdc-450b7b5f7a92	2024-01-10	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