Application 204661

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204661-001	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2017-06-13
A204661-002	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL			2017-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204661-001	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 · 86 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
2026-09-14 22:38:34	2026-08	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204661-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204661-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204661-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204661-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204661-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204661-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204661-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204661-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204661-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204661-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204661-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204661-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204661-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204661-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204661-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204661-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204661-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204661-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204661-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204661-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204661-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204661-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204661-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204661-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204661-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204661-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204661-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204661-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204661-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204661-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204661-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204661-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204661-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204661-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204661-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204661-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204661-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204661-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204661-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204661-001	AB	1	`3f0d92c62455…`

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 13 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Omeprazole	OMEPRAZOLE	L. Perrigo Company	db333c49-2c3e-4ade-a202-7d4499205fc4	2024-03-24	Warnings	Name fallback generic name: OMEPRAZOLE
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	907e9974-46b8-4dae-be92-518c076cb98f	2024-03-07	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Walgreen Company	b7972f17-4a63-4d78-a181-01ea6d7d3963	2024-03-04	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	OHM LABORATORIES INC.	35a95bec-51b9-465b-aa93-ad26afb87be8	2024-02-29	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	1c99e189-93c0-4461-82c2-4521e6c4d514	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
foster and thrive omeprazole	OMEPRAZOLE	Strategic Sourcing Services LLC	836efc63-b633-497c-ab56-76bb495bd723	2024-02-20	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aurohealth LLC	19097902-a5e6-423a-8569-31c569cd3cdb	2024-02-19	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a656a059-2b1a-44b3-85f8-af278032b54c	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a52842ac-ac9d-4344-9823-b8b2afb07903	2023-12-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	VALU MERCHANDISERS COMPANY	7b2d41b6-3e36-4973-b5f6-adf9b828f40d	2023-12-13	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	DISCOUNT DRUG MART	ff2c8446-9d8b-4300-b157-884b48e98bb7	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Best Choice	43ea758b-6cea-44a2-b4d6-8f99211c8826	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	RELIABLE 1 LABORATORIES LLC	f6b13640-6c71-4c3d-8eb5-c36fca201aee	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	7-Eleven	61206416-e0c1-44d7-ad35-feb629361ba9	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8f13fd38-dc73-4072-bdc9-9474704a4121	2023-11-22	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole/Sodium Bicarbonate	OMEPRAZOLE	Strides Pharma Science Limited	cf6d293e-d70d-443e-8292-d693e93aab55	2023-09-21	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	BluePoint Laboratories	a86d52a5-15e2-012d-e053-2a95a90ac912	2023-09-13	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68	2023-09-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	78743f3b-257e-49df-98cd-6cc0e1b4e370	2023-08-16	Warnings	Name fallback generic name: OMEPRAZOLE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5294	Omeprazole	Omeprazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5294	Omeprazole	Omeprazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
60429-974	Omeprazole	Omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-974	Omeprazole	Omeprazole	Golden State Medical Supply, Inc.	ANDA	Current