Home Applications 208025 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 44 .
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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208025-001 LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL 2016-06-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 53 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N208025-001 11077055 2036-04-21 Drug product 2021-08-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208025-001 11986554 2036-04-21 Drug product 2024-05-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208025-001 11077055 2036-04-21 Drug product 2021-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208025-001 11986554 2036-04-21 Drug product 2024-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208025-001 11077055 2036-04-21 Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208025-001 11986554 2036-04-21 Drug product 2024-05-21 caaa826d4ba7…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…
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 · 8 matching rows.
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 · 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