Application 205868

Type: ANDA
Sponsor: INVENTIA

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 1.

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
A205868-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-08-30
A205868-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205868-001	AB
A205868-002	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 3 · 82 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	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205868-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205868-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-08-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A205868-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205868-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205868-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205868-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205868-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205868-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205868-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205868-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205868-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205868-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205868-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205868-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205868-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205868-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205868-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205868-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205868-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205868-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205868-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205868-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205868-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205868-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205868-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205868-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205868-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205868-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205868-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205868-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205868-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205868-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205868-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205868-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205868-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205868-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205868-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205868-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205868-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205868-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205868-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205868-002	AB	1	`782e0a99824c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals, Inc.	7286d6a5-611b-4993-ab93-4899d599435d	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 68788-7742
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	1c364fc5-eb43-b12f-e063-6294a90a4319	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	ce1a4f32-da65-29d3-e053-2995a90a42ee	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 80425-0174
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	8f0d3f2f-91d9-467a-a841-540664af80f9	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 71335-1425
Lansoprazole DR	LANSOPRAZOLE DR	Direct_Rx	e5bcfc5b-f5a9-3260-e053-2a95a90ab70e	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 72189-370
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	b12cca1c-da28-67e2-e053-2a95a90aaf6b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 68071-2274
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	9a277b9e-2e13-27c3-e053-2995a90a7ed5	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 68071-5119
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	495d3ca8-d37d-440a-80ce-9342d9ff281a	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 50090-6079
Lansoprazole	LANSOPRAZOLE	Lifestar Pharma LLC.	afcc0f14-8b00-41ac-8e62-4094a15b959c	2022-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205868 application number: ANDA205868 ndc (product): 70756-807 ndc (product): 70756-806

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6079	Lansoprazole	Lansoprazole	A-S Medication Solutions	ANDA	Current
68071-2274	Lansoprazole	Lansoprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2274	Lansoprazole	Lansoprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5119	Lansoprazole	Lansoprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5119	Lansoprazole	Lansoprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5119	Lansoprazole	Lansoprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5119	Lansoprazole	Lansoprazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7742	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7742	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7742	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70756-806	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-806	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-806	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-806	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-806	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-807	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-807	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-807	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-807	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
70756-807	Lansoprazole	Lansoprazole	Lifestar Pharma LLC.	ANDA	Current
71335-1425	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-1425	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-1425	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-2078	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
72189-279	LANSOPRAZOLE	LANSOPRAZOLE	DirectRx	ANDA	Current
72189-279	LANSOPRAZOLE	LANSOPRAZOLE	DirectRx	ANDA	Current
72189-370	Lansoprazole DR	Lansoprazole DR	Direct_Rx	ANDA	Current
80425-0174	Lansoprazole DR	Lansoprazole DR	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0174	Lansoprazole	Lansoprazole	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0174	Lansoprazole	Lansoprazole	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0174	Lansoprazole	Lansoprazole	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current