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 6 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
omeprazole	OMEPRAZOLE	Kroger Company	da18d91c-5fe9-44d4-9d6f-602900af3f08	2025-06-04	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	P & L Development, LLC	44a92926-1941-4fe8-9b2a-31a45289456f	2025-06-02	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Sun Pharmaceutical Industries, Inc.	51c3ef34-b7c1-419e-a784-ae82540c7a22	2025-04-28	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	0fb314cb-6291-422c-98ff-24d8449992f6	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
careone omeprazole	OMEPRAZOLE	Retail Business Services, LLC	063cfad8-3ca6-4b72-a4c9-512b8047bae3	2025-04-17	Warnings	Name fallback generic name: OMEPRAZOLE
leader omeprazole	OMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	19beab17-ca25-4be3-bada-20a2e9aa26b5	2025-04-16	Warnings	Name fallback generic name: OMEPRAZOLE
rugby omeprazole	OMEPRAZOLE	Rugby Laboratories	61952807-f38d-4e7a-8646-a8ec85d7fb37	2025-04-15	Warnings	Name fallback generic name: OMEPRAZOLE
careone omeprazole	OMEPRAZOLE	American Sales Company	a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d	2025-04-14	Warnings	Name fallback generic name: OMEPRAZOLE
signature care omeprazole	OMEPRAZOLE	Safeway	85ece978-3cfb-4c09-bf0f-3217fda8e7d4	2025-04-14	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	BI-MART	fb089d15-daa4-477a-be83-ecd55c3283d4	2025-04-03	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	e87d2206-9c06-438c-947b-10b29a879d7b	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2e5d1b21-6b32-0c8d-e063-6294a90a8431	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE MAGNESIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	8edfcc08-a14e-4579-bd44-045267de5b79	2025-04-02	Warnings	Name fallback brand name: omeprazole
omeprazole	OMEPRAZOLE	Kroger Company	083841e8-482d-4e5b-90ab-1139b576d691	2025-03-31	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	54fd9f84-9c67-4846-b79d-eb9e6720a315	2025-03-31	Warnings	Name fallback generic name: OMEPRAZOLE
Signature Care Omeprazole	OMEPRAZOLE	Safeway	c76c4235-92d4-4384-8ddc-ceed0b928c48	2025-03-31	Warnings	Name fallback generic name: OMEPRAZOLE
equate omeprazole	OMEPRAZOLE	WALMART INC.	dcfe8e94-9c88-464e-9a80-3baa9c4755d9	2025-03-27	Warnings	Name fallback generic name: OMEPRAZOLE
equate omeprazole	OMEPRAZOLE	Wal-Mart Stores Inc	504b8282-d93f-454f-9f93-84cb8a9105d7	2025-03-25	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Allegiant Health	3344c589-c4ac-4f2d-8d32-828db4e825a6	2025-03-19	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	30955530-56d2-174d-e063-6294a90a413c	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: Omeprazole 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