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 10 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
omeprazole	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	7535a309-1a67-4f50-911b-7cf570322931	2024-10-30	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	44349466-73ea-4053-8ff6-5b4b7372c9cd	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	03ac077f-3873-4087-96d0-89049161dea9	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	253451a6-02a9-4b27-aed7-f3dbc2e09682	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	f0f61a89-700d-481d-9255-6f9a9afa7025	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	CVS Pharmacy	19b5b960-cc4d-42d0-8c8a-04a355a4db92	2024-09-13	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	e4a68b0a-a550-4416-8911-1defe014ad89	2024-09-09	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	30e58465-c5d2-4925-85bb-53faa6135c5c	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	5ad413ed-a21b-4f8b-9322-8fbb813b14d3	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
TopCare Omeprazole delayed release	OMEPRAZOLE	Topco Associates LLC	8ed57521-e69a-4563-9ce2-4f6d667f065d	2024-08-30	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	1eb34cff-59c5-4411-b587-10207ffb58c4	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Living Better Brands LLC	1d500e2d-395b-437e-a95c-3922a71a0956	2024-08-12	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	73c36634-a70f-4641-910f-6cdda7fbcd36	2024-08-08	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	fe7d3352-d53f-4046-92ed-1eb5c917fbee	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8d925ca6-83f1-4263-8218-4bf7cc8ceb39	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	2b7491dd-19f5-42e0-b901-7ba71a3820c7	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	17664f71-154a-47c6-b83c-b349bbc8a98f	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9378c870-f2cc-4a60-b0fd-08a4d43857bc	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	ec9d8dab-480c-49bc-bdbb-bebcc7676d01	2024-08-06	Warnings	Name fallback generic name: OMEPRAZOLE
up and up omeprazole	OMEPRAZOLE	Target Corporation	2f2b26fe-dbc2-4185-8a27-6b166dd49ba2	2024-07-26	Warnings	Name fallback generic name: OMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

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