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 11 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9724601b-bb12-4eb2-bc2e-0532976bf5d1	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
up and up omeprazole	OMEPRAZOLE	Target Corporation	7dc339da-e90b-452b-b25e-8d7f3aa8bc18	2024-07-20	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCarePharmaceuticals, Inc.	4be616c4-1b9a-5654-e054-00144ff88e88	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	ad675ef6-5377-b9f2-e053-2995a90a06e9	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	6fa6afcf-33b3-3115-e053-2a91aa0abd0b	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	5564c9dc-6f99-6639-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	55a1fb3c-f040-2e39-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	1d4ecc1e-5180-f75e-e063-6394a90a51a6	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Meijer Distribution Inc	d54e1097-bd56-4371-8e59-8ceab1a5e824	2024-07-12	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Fred's, Inc.	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	CVS Pharmacy, Inc.	3349ee88-e53b-4586-8d28-20ecf8fcb1a5	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
good sense omeprazole delayed release	OMEPRAZOLE	L. Perrigo Company	38082e59-c509-4be5-b29c-33a97565df1c	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	3eb70031-6439-44cf-8056-3e2e1e4a7fa9	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	0edfa800-fb14-44dd-9c31-de930b864ef9	2024-06-25	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aurobindo Pharma Limited	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	2024-06-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Family Dollar Stores, LLC	6d8daf78-1672-4bbf-a022-514bf0a5ac9a	2024-06-17	Warnings	Name fallback generic name: OMEPRAZOLE
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	76b941f0-a02f-43e8-821e-09ccf675d944	2024-06-17	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	NORTHEAST PHARMA	35ceccb5-dc3d-4ee1-bdac-35cb52c22f59	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Cardinal Health	230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Bi-Mart	419659f9-098a-4a18-8bba-cd45157bfa50	2024-06-15	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