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 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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A204661-001	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2017-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204661-002	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2017-06-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 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	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…`
2023-05-13 08:27 UTC	2023-05	A204661-001	AB	1	`053a50430f4f…`

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 15 · 286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	ded0df8b-1813-4595-ac2b-5499704bfd48	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	6ea9a6f3-b756-4cdf-b3db-f666a2c17d66	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	96104ea6-c08f-40b5-83f5-d840b317f1fd	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	a19ce586-59b7-4c2e-9e8d-12e8f0f058e2	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0344268f-d8e6-48d5-b1e1-f750ed1d8a52	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	P & L Development, LLC	883e428a-e157-4bbf-8657-e7a93dc99e8c	2026-07-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	WALMART INC. (see also Equate)	d3c1ba08-680d-4e39-875c-1f1d42ae787c	2026-07-13	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	HAWAII REPACK, INC.	9359e826-5263-44fc-8dd3-9d0852fe42d6	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	dcaadc8c-32d1-476f-b821-973c012b7fa7	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
careone omeprazole	OMEPRAZOLE	American Sales Company	5b88717a-e90c-4e74-ae2a-29270e14a3cc	2026-07-08	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	4c0cf466-f9e8-390e-e063-6294a90a2ed8	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Unit Dose Solutions, Inc.	557d4c2c-5541-3a51-e063-6394a90ad278	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
GOOD SENSE OMEPRAZOLE	OMEPRAZOLE	L. Perrigo Company	b840439b-540b-465a-8faa-f7b1024c628e	2026-06-29	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	d9c8a242-bdba-4f92-8629-692b47ebba21	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	e67bf2c6-0618-48e0-aa08-705501d86431	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	db9f071b-85f4-061f-e053-2995a90a3ff5	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	6a1aeb95-5760-4363-816a-fa8305979c50	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	P & L Development, LLC	911a08c4-ba73-4600-a5f2-7f26ba8c8604	2026-06-25	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE

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