Application 207156

Type: ANDA
Sponsor: LANNETT CO INC

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
A207156-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-09-28
A207156-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207156-001	AB
A207156-002	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 · 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	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207156-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207156-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-09-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207156-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207156-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207156-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207156-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207156-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207156-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207156-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207156-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207156-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207156-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207156-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207156-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207156-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207156-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207156-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207156-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207156-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207156-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207156-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207156-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207156-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207156-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207156-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207156-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207156-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207156-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207156-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207156-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207156-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207156-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207156-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207156-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207156-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207156-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207156-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207156-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207156-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207156-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207156-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207156-002	AB	1	`74a2ff9319b5…`

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 3 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	bd278054-875e-4877-991c-cbdf3975f93e	2025-03-31	Warnings	Name fallback brand name: lansoprazole generic name: LANSOPRAZOLE
lansoprazole	LANSOPRAZOLE	Padagis Israel Pharmaceuticals Ltd	17f41872-f3d1-4b02-b6ce-0e731139495a	2025-03-26	Warnings	Name fallback brand name: lansoprazole generic name: LANSOPRAZOLE
equate lansoprazole	LANSOPRAZOLE	WALMART INC.	3a7aadbd-0a70-444f-95e1-cbde82781892	2025-03-14	Warnings	Name fallback generic name: LANSOPRAZOLE
dg health lansoprazole	LANSOPRAZOLE	Dolgencorp Inc	e6e3bcee-636f-4361-85f8-9ba5a0f3c741	2025-03-04	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Quallent Pharmaceuticals Health LLC	cc006372-32d3-4539-921a-6bc9ec496b28	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
equaline lansoprazole	LANSOPRAZOLE	United Natural Foods, Inc. dba UNFI	bf8c337c-4a45-46e6-ae8e-46df80ca66e3	2025-02-13	Warnings	Name fallback generic name: LANSOPRAZOLE
lansoprazole	LANSOPRAZOLE	Publix Super Markets Inc	86a99ee3-0e98-46e8-8473-f8c812044a2f	2025-02-13	Warnings	Name fallback brand name: lansoprazole generic name: LANSOPRAZOLE
topcare lansoprazole	LANSOPRAZOLE	Topco Associates LLC	73aec019-5337-48a4-b95c-993fff9cfc2a	2025-02-13	Warnings	Name fallback generic name: LANSOPRAZOLE
Kirkland Signature Lansoprazole	LANSOPRAZOLE	Costco Wholesale Company	326aabe6-c4ac-4bca-949f-38015dcbaf4e	2025-02-12	Warnings	Name fallback generic name: LANSOPRAZOLE
lansoprazole	LANSOPRAZOLE	Kroger Company	4c0684b5-5c18-4ed5-8185-8b5d51dce3a0	2025-02-08	Warnings	Name fallback brand name: lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	CVS Pharmacy	992a8f95-475c-4e57-90cc-9839c8678427	2025-02-08	Warnings	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
topcare Lansoprazole	LANSOPRAZOLE	Topco Associates LLC	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	2025-02-08	Warnings	Name fallback generic name: LANSOPRAZOLE
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	6b57eb00-74fd-435f-bd08-086c9f8ac62c	2025-02-05	Warnings	Name fallback generic name: LANSOPRAZOLE
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	d86585b7-e146-4f04-9016-412b16e06f55	2025-01-29	Warnings	Name fallback generic name: LANSOPRAZOLE
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	f39feec2-54fb-47d4-9b45-08f75e92117e	2025-01-24	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	American Health Packaging	dee80a19-e514-41e6-9153-c959699d97b1	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	1c364fc5-eb43-b12f-e063-6294a90a4319	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	1bbb8f3a-80bf-b881-e063-6294a90ab4f2	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Lansoprazole generic name: LANSOPRAZOLE
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	ce1a4f32-da65-29d3-e053-2995a90a42ee	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c77da981-9260-fabd-e053-2a95a90aa71c	2024-12-31	Warnings, Adverse reactions	Name fallback 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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-433	Lansoprazole	Lansoprazole	AvKARE, Inc	ANDA	Current
42291-433	Lansoprazole	Lansoprazole	AvKARE	ANDA	Current
42291-434	Lansoprazole	Lansoprazole	AvKARE, Inc	ANDA	Current
42291-434	Lansoprazole	Lansoprazole	AvKARE	ANDA	Current
50090-4596	Lansoprazole	Lansoprazole	A-S Medication Solutions	ANDA	Current
50090-4596	Lansoprazole	Lansoprazole	A-S Medication Solutions	ANDA	Current
55700-814	Lansoprazole	Lansoprazole	Quality Care Products, LLC	ANDA	Current
62175-415	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-415	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-415	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-415	Lansoprazole	Lansoprazole	Lannett Company, Inc..	ANDA	Current
62175-415	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-430	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-430	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-430	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
62175-430	Lansoprazole	Lansoprazole	Lannett Company, Inc..	ANDA	Current
62175-430	Lansoprazole	Lansoprazole	Lannett Company, Inc.	ANDA	Current
68788-7789	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7789	Lansoprazole	Lansoprazole	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-1521	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-1521	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-1521	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current