Application 202319

Type: ANDA
Sponsor: PERRIGO R AND D

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202319-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2012-05-18

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`f41ea6bd6efb…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LANSOPRAZOLE	LANSOPRAZOLE	Amazon.com Services LLC	a8d09f97-4c39-4aa7-a9a0-4fd2a59836bb	2026-08-03	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
careone acid reducer	LANSOPRAZOLE	Retail Business Services, LLC	e6b42dec-3545-483f-97db-9375b3732fba	2026-07-08	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 72476-020
BERKLEY AND JENSEN LANSOPRAZOLE	LANSOPRAZOLE	BJWC	b859e8dc-e42e-448d-89fa-2fc79d9cac32	2026-05-21	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
good neighbor pharmacy lansoprazole	LANSOPRAZOLE	Amerisource Bergen	a4ee8db4-8f8e-4326-bd32-43abd53be8e4	2025-12-01	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
Prevacid 24 HR	LANSOPRAZOLE	L. Perrigo Company	205c9c1e-b422-4e86-a4b0-714b608adc19	2025-06-24	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Meijer Distribution Inc	b202a695-4265-4b3b-bab8-593d47962382	2025-06-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Walgreen Company	afcd7c51-9333-4d6f-ad18-ed95baecc7ce	2025-05-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
up and up lansoprazole	LANSOPRAZOLE	Target Corporation	16ceaead-8dc0-49de-9438-caa146e13fba	2025-04-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	bd278054-875e-4877-991c-cbdf3975f93e	2025-03-31	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Padagis Israel Pharmaceuticals Ltd	17f41872-f3d1-4b02-b6ce-0e731139495a	2025-03-26	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
equate lansoprazole	LANSOPRAZOLE	WALMART INC.	3a7aadbd-0a70-444f-95e1-cbde82781892	2025-03-14	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 79903-068
dg health lansoprazole	LANSOPRAZOLE	Dolgencorp Inc	e6e3bcee-636f-4361-85f8-9ba5a0f3c741	2025-03-04	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
equaline lansoprazole	LANSOPRAZOLE	United Natural Foods, Inc. dba UNFI	bf8c337c-4a45-46e6-ae8e-46df80ca66e3	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Publix Super Markets Inc	86a99ee3-0e98-46e8-8473-f8c812044a2f	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 56062-283
topcare lansoprazole	LANSOPRAZOLE	Topco Associates LLC	73aec019-5337-48a4-b95c-993fff9cfc2a	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
Kirkland Signature Lansoprazole	LANSOPRAZOLE	Costco Wholesale Company	326aabe6-c4ac-4bca-949f-38015dcbaf4e	2025-02-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 63981-582
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	6b57eb00-74fd-435f-bd08-086c9f8ac62c	2025-02-05	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 72288-343
Members Mark Lansoprazole	LANSOPRAZOLE	Sam's West Inc	fee84ce3-a884-4944-a32b-72e69a1229d4	2024-07-15	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	91d69826-df5c-47a2-b852-3083629d1893	2024-06-17	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
foster and thrive acid reducer	LANSOPRAZOLE	Strategic Sourcing Services LLC	d02e2f93-3358-4682-b491-0a83889af8a1	2023-09-14	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319

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 2 of 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
56062-283	lansoprazole	Lansoprazole	Publix Super Markets Inc	ANDA	Current
56062-283	lansoprazole	Lansoprazole	Publix Super Markets Inc	ANDA	Current
59779-117	lansoprazole	Lansoprazole	CVS Pharmacy	ANDA	Current
59779-117	lansoprazole	Lansoprazole	CVS Pharmacy	ANDA	Current
59779-117	lansoprazole	Lansoprazole	CVS Pharmacy	ANDA	Current
62011-0168	health mart lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
62011-0168	health mart lansoprazole	Lansoprazole	McKesson	ANDA	Current
62011-0168	health mart lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
62011-0472	Health Mart lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
63629-4851	lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-4851	lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-4851	lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63981-117	Kirkland Signature Lansoprazole Delayed Release	Lansoprazole	Costco Wholesale Company	ANDA	Current
63981-117	Kirkland Signature Lansoprazole Delayed Release	Lansoprazole	Costco Wholesale Company	ANDA	Current
63981-117	Kirkland Signature Lansoprazole Delayed Release	Lansoprazole	Costco Wholesale Company	ANDA	Current
63981-117	Kirkland Signature Lansoprazole Delayed Release	Lansoprazole	Costco Wholesale Company	ANDA	Current
63981-582	Kirkland Signature Lansoprazole	Lansoprazole	Costco Wholesale Company	ANDA	Current
63981-582	Kirkland Signature Lansoprazole	Lansoprazole	Costco Wholesale Company	ANDA	Current
68196-020	members mark lansoprazole	Lansoprazole	Sam's West Inc	ANDA	Current
68391-117	Berkley and Jensen Lansoprazole	Lansoprazole	BJWC	ANDA	Current
68391-117	Berkley and Jensen Lansoprazole	Lansoprazole	BJWC	ANDA	Current
68391-117	Berkley and Jensen Lansoprazole	Lansoprazole	BJWC	ANDA	Current
69256-401	harris teeter acid reducer	Lansoprazole	Harris Teeter, LLC	ANDA	Current
69256-401	harris teeter acid reducer	Lansoprazole	Harris Teeter, LLC	ANDA	Current
69256-401	harris teeter acid reducer	Lansoprazole	Harris Teeter, LLC	ANDA	Current
70000-0414	Leader lansoprazole	Lansoprazole	Cardinal Health	ANDA	Current
70000-0414	Leader lansoprazole	Lansoprazole	Cardinal Health	ANDA	Current
70000-0414	Leader lansoprazole	Lansoprazole	Cardinal Health	ANDA	Current
70677-0124	sunmark lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
70677-0124	sunmark lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
71335-0575	lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-0575	lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-0575	lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
72288-301	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72288-301	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72288-301	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72288-343	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72288-343	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72288-343	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72288-343	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	ANDA	Current
72476-020	careone acid reducer	Lansoprazole	Retail Business Services, LLC	ANDA	Current
72476-020	careone acid reducer	Lansoprazole	Retail Business Services, LLC	ANDA	Current
79903-068	equate lansoprazole	Lansoprazole	WALMART INC.	ANDA	Current
79903-068	equate lansoprazole	Lansoprazole	WALMART INC.	ANDA	Current
81522-001	caring mill lansoprazole	Lansoprazole	FSA Store Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10022	ORIG	2012-05-22