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 7 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	CVS Pharmacy	01bde9ca-0114-426d-8188-c55aefaa0961	2025-03-05	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	H E B	501d80c0-68ee-4fd9-bc56-0b214dbf72b5	2025-02-27	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	40f66cac-bc23-43f9-9966-87cce458c996	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Asclemed USA, Inc.	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Padagis Israel Pharmaceuticals Ltd	cb47354c-297b-4dc2-85af-242acc967b56	2025-02-06	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Signature Care Omeprazole	OMEPRAZOLE	Safeway	6361a492-782f-4608-a20f-1bd86afbd864	2025-02-06	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	H E B	5ceaec04-3ca3-4c7c-9184-51a42686a595	2025-02-05	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
kirkland signature omeprazole	OMEPRAZOLE	Costco Wholesale Company	48a44d0c-3502-430b-8b75-188a49d14da2	2025-02-05	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Meijer Distribution Inc	925399c7-dcbc-4546-9111-2a98a11ba538	2025-02-05	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	436c5ea1-c5ee-481f-803d-439f65873b1c	2025-01-31	Warnings	Name fallback generic name: OMEPRAZOLE
up and up omeprazole	OMEPRAZOLE	Target Corporation	8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56	2025-01-31	Warnings	Name fallback generic name: OMEPRAZOLE
DG health omperazole	OMEPRAZOLE	Dolgencorp Inc	99fdfeed-6828-4bf6-bb81-cd29a4ec610b	2025-01-31	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	H E B	344b5548-e5c0-45bf-bc3f-73af50bd5913	2025-01-30	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Coupler LLC	2cdc6809-3b1b-046a-e063-6394a90ae02a	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Basic Care Omeprazole	OMEPRAZOLE	Amazon.com Services LLC	87a2aa9b-c681-41c7-8a59-b359efd443cb	2025-01-22	Warnings	Name fallback generic name: OMEPRAZOLE
good sense omeprazole	OMEPRAZOLE	L. Perrigo Company	dcd93796-8904-415d-a379-c4ea590cf544	2025-01-22	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Walgreen Company	064f048c-eddd-4370-9ee4-706f9f00c8d2	2025-01-22	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	a806da8c-5f84-454d-966c-da1c48710f80	2025-01-20	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.