Application 210070

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	TABLET, DELAYED RELEASE;ORAL	20MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210070-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL			2019-02-11

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210070-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2019-02-11	`f41ea6bd6efb…`

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 14 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	STRATEGIC SOURCING SERVICES LLC	56380ccc-6fc2-4e1b-bd87-da24c9aa31cd	2023-08-14	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	b6c87a6a-253a-4455-9b7d-62f506da592e	2023-08-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	13b379ef-7982-434d-9e6b-e01cd2b398d2	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	39e3b45a-8e9b-49d6-976a-6668f4e27649	2023-07-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	c5af5f4b-17be-7245-b281-f27c87831242	2023-06-20	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Zydus Pharmaceuticals USA Inc.	9c22ceb2-2c34-43c3-9a35-2589c9078741	2023-05-11	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Sandoz Inc	e4562da8-9d94-4417-9f80-c1ffd4247259	2023-04-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Lannett Company, Inc.	92201fb1-4570-42db-8da3-3b8c0e291d32	2023-04-21	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Walgreen Company	87cee50d-4c1e-473d-9d70-b1622f84aee1	2023-03-17	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	a53ea447-add5-4ed5-aa7e-975b13d90e75	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	THE KROGER COMPANY	f55cedc7-e0bc-4d30-af52-bfa881f6adde	2023-01-06	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Twin Med LLC	346141b5-b49d-489a-84eb-18df8b940460	2023-01-06	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	HARRIS TEETER	c618964f-4b16-448e-851b-e6b2a816c660	2022-12-27	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Camber Consumer Care Inc	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	2022-11-28	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	9786b04f-f827-460b-91bc-c0ac967f95dd	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Strategic Sourcing Services	dfa91081-3917-4dfc-9789-76800f57bb31	2022-05-11	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	2d99b4fd-49b3-403d-96a4-0cceda85a95c	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	2fc5065c-5850-469b-b357-fa4df30a8f78	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Rite Aid	b1ba65d1-8f68-4bae-bb9d-776bba348346	2022-03-03	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Xiromed, LLC	38bd8e13-591e-f11b-7d8a-11717c56493c	2022-02-15	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.