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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`cb3db0bc1861…`

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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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 ndc (product): 46122-698
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 ndc (product): 41250-391
lansoprazole	LANSOPRAZOLE	Walgreen Company	afcd7c51-9333-4d6f-ad18-ed95baecc7ce	2025-05-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 0363-1212
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 ndc (product): 11673-280
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 ndc (product): 45802-878
equate lansoprazole	LANSOPRAZOLE	WALMART INC.	3a7aadbd-0a70-444f-95e1-cbde82781892	2025-03-14	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
dg health lansoprazole	LANSOPRAZOLE	Dolgencorp Inc	e6e3bcee-636f-4361-85f8-9ba5a0f3c741	2025-03-04	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 55910-307
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 ndc (product): 41163-150
lansoprazole	LANSOPRAZOLE	Publix Super Markets Inc	86a99ee3-0e98-46e8-8473-f8c812044a2f	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
topcare lansoprazole	LANSOPRAZOLE	Topco Associates LLC	73aec019-5337-48a4-b95c-993fff9cfc2a	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (product): 36800-392
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
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
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 ndc (product): 0113-1114
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
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	5ab07bf7-140a-4ca0-9b3a-38da7aa454db	2022-12-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0117	Good Sense lansoprazole	Lansoprazole	L. Perrigo Company	ANDA	Current
0113-0117	Good Sense lansoprazole	Lansoprazole	L. Perrigo Company	ANDA	Current
0113-0117	Good Sense lansoprazole	Lansoprazole	L. Perrigo Company	ANDA	Current
0113-1114	Good Sense Lansoprazole	Lansoprazole	L. Perrigo Company	ANDA	Current
0113-7003	Basic Care Lansoprazole	Lansoprazole	L. Perrigo Company	ANDA	Current
0113-7003	Basic Care Lansoprazole	Lansoprazole	L. Perrigo Company	ANDA	Current
0363-0117	well at walgreens lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0363-1212	lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0363-1212	lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0363-1212	lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0363-4069	Lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0363-4069	Lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0363-4069	Lansoprazole	Lansoprazole	Walgreen Company	ANDA	Current
0536-1034	Rugby Heartburn Treatment	Lansoprazole	Rugby Laboratories	ANDA	Current
0536-1034	Rugby Heartburn Treatment	Lansoprazole	Rugby Laboratories	ANDA	Current
0536-1034	Rugby Heartburn Treatment	Lansoprazole	Rugby Laboratories	ANDA	Current
11673-117	up and up lansoprazole	Lansoprazole	Target Corporation	ANDA	Current
11673-117	up and up lansoprazole	Lansoprazole	Target Corporation	ANDA	Current
11673-117	up and up lansoprazole	Lansoprazole	Target Corporation	ANDA	Current
11673-280	up and up lansoprazole	Lansoprazole	Target Corporation	ANDA	Current
11673-280	up and up lansoprazole	Lansoprazole	Target Corporation	ANDA	Current
11822-0117	lansoprazole	Lansoprazole	Rite Aid Corporation	ANDA	Current
21130-181	signature care acid reducer	Lansoprazole	Safeway	ANDA	Current
21130-181	signature care acid reducer	Lansoprazole	Safeway	ANDA	Current
21130-181	signature care acid reducer	Lansoprazole	Safeway	ANDA	Current
21130-564	safeway acid reducer	Lansoprazole	Safeway	ANDA	Current
21130-564	safeway acid reducer	Lansoprazole	Safeway	ANDA	Current
30142-117	Lansoprazole	Lansoprazole	Kroger Company	ANDA	Current
30142-117	Lansoprazole	Lansoprazole	Kroger Company	ANDA	Current
30142-117	Lansoprazole	Lansoprazole	Kroger Company	ANDA	Current
36800-117	Topcare Lansoprazole	Lansoprazole	Topco Associates LLC	ANDA	Current
36800-117	Topcare Lansoprazole	Lansoprazole	Topco Associates LLC	ANDA	Current
36800-117	Topcare Lansoprazole	Lansoprazole	Topco Associates LLC	ANDA	Current
36800-392	topcare lansoprazole	Lansoprazole	Topco Associates LLC	ANDA	Current
36800-392	topcare lansoprazole	Lansoprazole	Topco Associates LLC	ANDA	Current
37012-117	Lansoprazole	Lansoprazole	Shopko Stores Operating Co., LLC	ANDA	Current
37012-117	Lansoprazole	Lansoprazole	Shopko Stores Operating Co., LLC	ANDA	Current
37205-661	Leader Lansoprazole	Lansoprazole	Cardinal Health	ANDA	Current
37808-117	lansoprazole	Lansoprazole	H E B	ANDA	Current
41163-117	equaline lansoprazole	Lansoprazole	Supervalu Inc	ANDA	Current
41163-117	equaline lansoprazole	Lansoprazole	Supervalu Inc	ANDA	Current
41163-117	equaline lansoprazole	Lansoprazole	Supervalu Inc	ANDA	Current
41163-150	equaline lansoprazole	Lansoprazole	Supervalu Inc	ANDA	Current
41190-117	ShopRite Lansoprazole	Lansoprazole	Wakefern Food Corporation	ANDA	Current
41250-117	lansoprazole	Lansoprazole	Meijer Distribution Inc	ANDA	Current
41250-117	lansoprazole	Lansoprazole	Meijer Distribution Inc	ANDA	Current
41250-117	lansoprazole	Lansoprazole	Meijer Distribution Inc	ANDA	Current
41250-391	lansoprazole	Lansoprazole	Meijer Distribution Inc	ANDA	Current
41250-391	lansoprazole	Lansoprazole	Meijer Distribution Inc	ANDA	Current
41250-391	lansoprazole	Lansoprazole	Meijer Distribution Inc	ANDA	Current
41520-816	CareOne Acid Reducer	Lansoprazole	American Sales Company	ANDA	Current
41520-816	CareOne Acid Reducer	Lansoprazole	American Sales Company	ANDA	Current
41520-816	CareOne Acid Reducer	Lansoprazole	American Sales Company	ANDA	Current
45802-245	lansoprazole	Lansoprazole	Perrigo New York Inc	ANDA	Current
45802-245	lansoprazole	Lansoprazole	Perrigo New York Inc	ANDA	Current
45802-245	lansoprazole	Lansoprazole	Perrigo New York Inc	ANDA	Current
45802-245	lansoprazole	Lansoprazole	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-878	lansoprazole	Lansoprazole	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
46122-107	Good Neighbor Pharmacy Lansoprazole	Lansoprazole	Amerisource Bergen	ANDA	Current
46122-107	Good Neighbor Pharmacy Lansoprazole	Lansoprazole	Amerisource Bergen	ANDA	Current
46122-107	Good Neighbor Pharmacy Lansoprazole	Lansoprazole	Amerisource Bergen	ANDA	Current
46122-698	good neighbor pharmacy lansoprazole	Lansoprazole	Amerisource Bergen	ANDA	Current
46122-698	good neighbor pharmacy lansoprazole	Lansoprazole	Amerisource Bergen	ANDA	Current
49035-411	equate lansoprazole delayed release	Lansoprazole	Wal-Mart Stores Inc	ANDA	Current
49035-411	equate lansoprazole delayed release	Lansoprazole	Wal-Mart Stores Inc	ANDA	Current
49035-411	equate lansoprazole delayed release	Lansoprazole	Wal-Mart Stores Inc	ANDA	Current
49348-301	sunmark lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
49348-301	sunmark lansoprazole	Lansoprazole	McKesson	ANDA	Current
49348-301	sunmark lansoprazole	Lansoprazole	Strategic Sourcing Services LLC	ANDA	Current
49738-401	smart sense lansoprazole	Lansoprazole	Kmart Corporation	ANDA	Current
50594-026	Sound Body Acid Reducer	Lansoprazole	Big Lots Stores, Inc.	ANDA	Current
55316-117	healthy accents lansoprazole	Lansoprazole	DZA Brands LLC	ANDA	Current
55910-117	dg health lansoprazole	Lansoprazole	Dolgencorp, LLC	ANDA	Current
55910-117	dg health lansoprazole	Lansoprazole	Dolgencorp, LLC	ANDA	Current
55910-117	dg health lansoprazole	Lansoprazole	Dolgencorp, LLC	ANDA	Current
55910-307	dg health lansoprazole	Lansoprazole	Dolgencorp Inc	ANDA	Current
55910-307	dg health lansoprazole	Lansoprazole	Dolgencorp Inc	ANDA	Current
56062-117	lansoprazole	Lansoprazole	Publix Super Markets Inc	ANDA	Current
56062-117	lansoprazole	Lansoprazole	Publix Super Markets Inc	ANDA	Current
56062-117	lansoprazole	Lansoprazole	Publix Super Markets Inc	ANDA	Current

Documents#

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