Application 203481

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	No	No
002	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	No	No
003	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203481-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03
A203481-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03
A203481-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203481-001	AB
A203481-002	AB
A203481-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203481-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-07-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203481-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203481-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203481-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203481-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203481-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203481-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203481-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203481-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203481-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203481-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203481-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203481-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203481-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203481-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203481-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203481-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203481-001	AB	1	`8072bd15b7f6…`

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
OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply, Inc.	f27b3518-d5c1-1229-e053-2a95a90ab56f	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203481 application number: ANDA203481
OMEPRAZOLE	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3e99b78b-7fb8-4514-a3db-58e59cd429d8	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203481 application number: ANDA203481

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-129	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply Inc.	ANDA	Current
51407-129	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply, Inc.	ANDA	Current
51407-129	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-129	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-129	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-129	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-130	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply Inc.	ANDA	Current
51407-130	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply, Inc.	ANDA	Current
51407-130	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-130	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-130	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51407-130	OMEPRAZOLE	OMEPRAZOLE	Golden State Medical Supply	ANDA	Current
51991-642	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-642	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-642	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-642	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-643	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-643	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-643	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-643	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-643	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-643	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-644	OMEPRAZOLE	OMEPRAZOLE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
55700-693	OMEPRAZOLE	OMEPRAZOLE	Quality Care Products, LLC	ANDA	Current
68788-7896	OMEPRAZOLE	OMEPRAZOLE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7898	OMEPRAZOLE	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-433	OMEPRAZOLE	OMEPRAZOLE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-433	OMEPRAZOLE	OMEPRAZOLE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-433	OMEPRAZOLE	OMEPRAZOLE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-433	OMEPRAZOLE	OMEPRAZOLE	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-959	OMEPRAZOLE	OMEPRAZOLE	Proficient Rx LP	ANDA	Current
71205-960	OMEPRAZOLE	OMEPRAZOLE	Proficient Rx LP	ANDA	Current
71610-297	OMEPRAZOLE	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-326	OMEPRAZOLE	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current