Application 203203

Type: ANDA
Sponsor: XIROMED

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
002	LANSOPRAZOLE	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203203-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-07-25
A203203-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203203-001	AB
A203203-002	AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-07-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203203-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203203-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203203-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203203-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203203-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203203-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203203-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203203-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203203-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203203-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203203-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203203-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203203-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203203-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203203-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203203-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203203-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203203-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203203-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203203-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203203-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203203-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203203-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203203-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203203-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203203-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203203-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203203-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203203-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203203-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203203-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203203-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203203-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203203-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203203-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203203-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203203-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203203-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203203-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203203-002	AB	1	`bb7c543d1eb4…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals Inc.	db42468a-450c-4b12-b2f2-e9a76e976d45	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	3babf7d9-ad83-4e44-8e5d-f6c11b2d76b6	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 50090-6154
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	16dc1e02-4679-4d7f-a65b-6e3706655d35	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	37b221ee-b6a4-76e8-e063-6394a90a7e0b	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Golden State Medical Supply, Inc.	a9dd7e56-1aee-5f0b-e053-2995a90a43bf	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 51407-324
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	11344047-7ed4-61e7-e063-6394a90a332d	2024-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e0299cf2-8a8e-499b-a81e-16e844ea3aff	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	ae03d05b-0a0f-4bae-bbdc-450b7b5f7a92	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 63629-2341
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	44f07613-35be-4673-98f0-4b2467acce9c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 63629-2340
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	1dc026b6-b521-4a46-9a74-8c1c140d5329	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 63629-2342
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	a612a237-ec17-49f0-8985-44407608adb5	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 71335-1820
Lansoprazole	LANSOPRAZOLE	Xiromed LLC	00a574e0-bd03-deea-9f85-b108f78982ba	2022-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 70700-263 ndc (product): 70700-262

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6154	Lansoprazole	Lansoprazole	A-S Medication Solutions	ANDA	Current
51407-324	Lansoprazole	Lansoprazole	Golden State Medical Supply	ANDA	Current
51407-324	Lansoprazole	Lansoprazole	Golden State Medical Supply	ANDA	Current
51407-324	Lansoprazole	Lansoprazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-324	Lansoprazole	Lansoprazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-324	Lansoprazole	Lansoprazole	Golden State Medical Supply, Inc.	ANDA	Current
63629-2340	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-2340	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-2341	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-2341	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-2342	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
63629-2342	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-262	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
70700-263	Lansoprazole	Lansoprazole	Xiromed LLC	ANDA	Current
71335-1820	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current
71335-1820	Lansoprazole	Lansoprazole	Bryant Ranch Prepack	ANDA	Current