Application 210593

Type: ANDA
Sponsor: SPIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED RELEASE;ORAL	EQ 20MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210593-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2018-07-20

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`cb3db0bc1861…`

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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
omeprazole	OMEPRAZOLE	Rite Aid	b1ba65d1-8f68-4bae-bb9d-776bba348346	2022-03-03	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 11822-0061
Omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	537b9a46-ecc8-4537-9657-c9ff7821dd4b	2021-12-03	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 0363-9980
Omeprazole	OMEPRAZOLE	CVS Pharamacy, Inc	0769e47f-f8f1-4b1c-a8cc-7c8385c74070	2021-04-16	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 51316-061
OMEPRAZOLE	OMEPRAZOLE	AMERISOURCE BERGEN	47dce86f-d184-44cf-8ee3-18dad7f401b8	2021-03-31	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 46122-686
Omeprazole	OMEPRAZOLE MAGNESIUM	UP & UP	ac10cf46-1dcc-483a-83d6-2fcb9896cc19	2020-12-04	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 11673-948
Omeprazole	OMEPRAZOLE	Meijer Distribution Inc.	8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573	2020-12-03	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 79481-0061
omeprazole	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	ce5c9fdc-0c50-4315-8f11-e00c9810abd0	2020-08-06	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 57483-740

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9980	Omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	ANDA	Current
0363-9980	Omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	ANDA	Current
11673-948	Omeprazole	Omeprazole Magnesium	UP & UP	ANDA	Current
11822-0061	omeprazole	omeprazole	Rite Aid	ANDA	Current
11822-0061	omeprazole	omeprazole	Rite Aid	ANDA	Current
46122-686	OMEPRAZOLE	OMEPRAZOLE	AMERISOURCE BERGEN	ANDA	Current
51316-061	Omeprazole	Omeprazole	CVS Pharamacy, Inc	ANDA	Current
51660-061	Omeprazole	Omeprazole	Ohm Laboratories Inc.	ANDA	Current
51660-061	Omeprazole	Omeprazole	Ohm Laboratories Inc.	ANDA	Current
57483-740	omeprazole	omeprazole	INNOVUS PHARMACEUTICALS, INC.	ANDA	Current
72559-010	Omeprazole	Omeprazole	Curist	ANDA	Current
72559-010	Omeprazole	Omeprazole	Little Pharma, Inc.	ANDA	Current
72559-010	Omeprazole	Omeprazole	Little Pharma, Inc.	ANDA	Current
72559-010	Omeprazole	Omeprazole	Curist	ANDA	Current
79481-0061	Omeprazole	Omeprazole	Meijer Distribution Inc.	ANDA	Current