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 8 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	64a62f09-19a9-4281-a55d-451fd33711c1	2025-01-17	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
dg health omeprazole	OMEPRAZOLE	Dolgencorp Inc	6d19783d-2856-4a86-9f5c-6cc26b4ca33e	2025-01-17	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Chain Drug Marketing Association INC	77d4f6c7-87ca-78bb-3310-2304a68f9f9b	2025-01-17	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	d1e0c8fc-1f15-45a4-a80f-653a1dae5e56	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Meijer Distribution Inc	4e849a58-ad34-4d6e-a065-d1e5a1ac8218	2025-01-16	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	H E B	491e3710-9a15-4b07-ae22-923bd1152ecc	2025-01-16	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
dg health omeprazole	OMEPRAZOLE	Dolgencorp Inc	3c34fa4b-be9f-4aa6-ab6b-775b528a8949	2025-01-16	Warnings	Name fallback generic name: OMEPRAZOLE
24 hr omeprazole	OMEPRAZOLE	Meijer, Inc.	36adb053-3189-4c91-87dd-e122a2c8e812	2025-01-14	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Camber Pharmaceuticals, Inc.	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	AvPAK	f77efc97-2565-38ab-e053-6394a90aebda	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	f226173f-4318-43e0-847a-8ea237e6b41d	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	CVS Pharmacy	fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512	2025-01-06	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
TopCare Omeprazole	OMEPRAZOLE	Topco Associates LLC	4d98665d-38db-4c08-8406-cc0e45f7ab7c	2025-01-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole DR	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	af85afda-6b0c-d657-e053-2a95a90afb4b	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole DR	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	af85e324-ef9f-196c-e053-2995a90a384e	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole DR	OMEPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Sandoz Inc	516170d4-4913-4577-a2d2-f5c52d1e79c6	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Sandoz Inc	5a09ce48-7139-4fc7-9b6e-439459c8e866	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
up and up omeprazole	OMEPRAZOLE	Target Corporation	d664c45d-564a-4692-ae8f-8dd980ffcd87	2024-12-30	Warnings	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Walgreen Company	30a893d2-198a-4184-81b4-02399324ff29	2024-12-20	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.