Application 208025

Type: NDA
Sponsor: DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANSOPRAZOLE	LANSOPRAZOLE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;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
N208025-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL			2016-06-07

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208025-001	11077055	2036-04-21		Drug product	2021-08-03
N208025-001	11986554	2036-04-21		Drug product	2024-05-21

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	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`053a50430f4f…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Walgreen Company	a72f92cc-db49-40ef-a249-6b7c50dc8ef2	2026-02-28	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 0363-1419
lansoprazole	LANSOPRAZOLE	Kroger Company	4c0684b5-5c18-4ed5-8185-8b5d51dce3a0	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 30142-192
Lansoprazole	LANSOPRAZOLE	CVS Pharmacy	992a8f95-475c-4e57-90cc-9839c8678427	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 69842-507
topcare Lansoprazole	LANSOPRAZOLE	Topco Associates LLC	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 36800-295
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	d86585b7-e146-4f04-9016-412b16e06f55	2025-01-29	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 0113-0116
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	f39feec2-54fb-47d4-9b45-08f75e92117e	2025-01-24	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 72288-829
equate lansoprazole	LANSOPRAZOLE	Wal-Mart Stores Inc	89b91d5f-008c-4e9d-83e0-23b673b9c469	2022-12-07	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 49035-373

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0116	Good Sense Lansoprazole	Lansoprazole	L. Perrigo Company	NDA	Current
0113-7116	basic care lansoprazole	Lansoprazole	L. Perrigo Company	NDA	Current
0113-7116	basic care lansoprazole	Lansoprazole	L. Perrigo Company	NDA	Current
0363-1419	Lansoprazole	Lansoprazole	Walgreen Company	NDA	Current
30142-192	lansoprazole	lansoprazole	Kroger Company	NDA	Current
30142-192	lansoprazole	lansoprazole	Kroger Company	NDA	Current
30142-192	lansoprazole	lansoprazole	Kroger Company	NDA	Current
36800-295	topcare Lansoprazole	lansoprazole	Topco Associates LLC	NDA	Current
49035-373	equate lansoprazole	lansoprazole	Wal-Mart Stores Inc	NDA	Current
49035-373	equate lansoprazole	lansoprazole	Wal-Mart Stores Inc	NDA	Current
49035-373	equate lansoprazole	lansoprazole	Wal-Mart Stores Inc	NDA	Current
69842-507	Lansoprazole	Lansoprazole	CVS Pharmacy	NDA	Current
69842-507	Lansoprazole	Lansoprazole	CVS Pharmacy	NDA	Current
72288-829	basic care lansoprazole	Lansoprazole	Amazon.com Services LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85365	SUPPL	2026-03-12
85364	SUPPL	2026-03-12
72572	SUPPL	2022-11-07
72535	SUPPL	2022-11-02
65313	SUPPL	2020-11-25
65308	SUPPL	2020-11-25
58457	SUPPL	2019-04-29
58280	SUPPL	2019-04-10
50591	SUPPL	2017-12-04
50590	SUPPL	2017-12-04
50588	SUPPL	2017-12-04
50568	SUPPL	2017-12-01
50418	SUPPL	2017-11-15
48377	SUPPL	2017-05-15
48368	SUPPL	2017-05-12
47013	SUPPL	2017-01-30
47009	SUPPL	2017-01-30
45930	ORIG	2016-11-22
32877	ORIG	2016-06-13