Application 203187

Type: ANDA
Sponsor: MYLAN

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 42.

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
A203187-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2016-06-01

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Rite Aid Corporation	5f256a0c-14df-4fd9-a818-b4276954152e	2025-08-25	Warnings	Exact identifier application applno (ANDA): 203187 application number: ANDA203187 ndc (product): 11822-3374
Lansoprazole	LANSOPRAZOLE	CVS Pharmacy	d52b26e2-3d2a-4067-a28b-8697f865f582	2025-08-20	Warnings	Exact identifier application applno (ANDA): 203187 application number: ANDA203187 ndc (product): 69842-755

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0536-1236	Lansoprazole	Lansoprazole	Rugby Laboratories, Inc.	ANDA	Current
0536-1236	Lansoprazole	Lansoprazole	Rugby Laboratories, Inc.	ANDA	Current
0536-1236	Lansoprazole	Lansoprazole	Rugby Laboratories, Inc.	ANDA	Current
11822-3374	Lansoprazole	Lansoprazole	Rite Aid Corporation	ANDA	Current
11822-3374	Lansoprazole	Lansoprazole	Rite Aid Corporation	ANDA	Current
11822-3374	Lansoprazole	Lansoprazole	Rite Aid Corporation	ANDA	Current
37808-755	Lansoprazole	Lansoprazole	H E B	ANDA	Current
37808-755	Lansoprazole	Lansoprazole	H E B	ANDA	Current
37808-755	Lansoprazole	Lansoprazole	H E B	ANDA	Current
37808-755	Lansoprazole	Lansoprazole	H E B	ANDA	Current
37808-755	Lansoprazole	Lansoprazole	H E B	ANDA	Current
68016-758	Lansoprazole	Lansoprazole	Chain Drug Consortium, LLC	ANDA	Current
68016-758	Lansoprazole	Lansoprazole	Chain Drug Consortium, LLC	ANDA	Current
68016-758	Lansoprazole	Lansoprazole	Chain Drug Consortium, LLC	ANDA	Current
68196-030	Lansoprazole	lansoprazole delayed release	Sam's West, Inc.	ANDA	Current
68196-030	Lansoprazole	lansoprazole delayed release	Sam's West, Inc.	ANDA	Current
69842-755	Lansoprazole	Lansoprazole	CVS Pharmacy	ANDA	Current
69842-755	Lansoprazole	Lansoprazole	CVS Pharmacy	ANDA	Current
69842-755	Lansoprazole	Lansoprazole	CVS Pharmacy	ANDA	Current
70000-0508	Lansoprazole	Lansoprazole	Cardinal Health (Leader) 70000	ANDA	Current
70000-0508	Lansoprazole	Lansoprazole	Cardinal Health (Leader) 70000	ANDA	Current
70000-0508	Lansoprazole	Lansoprazole	Cardinal Health (Leader) 70000	ANDA	Current
70000-0508	Lansoprazole	Lansoprazole	Cardinal Health (Leader) 70000	ANDA	Current