Application 022032

Type: NDA
Sponsor: DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	TABLET, DELAYED RELEASE;ORAL	20MG	Yes	Yes

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
N022032-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2007-12-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022032-001	12599565	2030-01-31		Drug product	2026-05-11

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`e64feba35796…`

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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	CVS Pharmacy	19b5b960-cc4d-42d0-8c8a-04a355a4db92	2024-09-13	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	e4a68b0a-a550-4416-8911-1defe014ad89	2024-09-09	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
TopCare Omeprazole delayed release	OMEPRAZOLE	Topco Associates LLC	8ed57521-e69a-4563-9ce2-4f6d667f065d	2024-08-30	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 36800-121
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	73c36634-a70f-4641-910f-6cdda7fbcd36	2024-08-08	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	ec9d8dab-480c-49bc-bdbb-bebcc7676d01	2024-08-06	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
up and up omeprazole	OMEPRAZOLE	Target Corporation	2f2b26fe-dbc2-4185-8a27-6b166dd49ba2	2024-07-26	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 11673-915
up and up omeprazole	OMEPRAZOLE	Target Corporation	7dc339da-e90b-452b-b25e-8d7f3aa8bc18	2024-07-20	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 11673-346
good sense omeprazole delayed release	OMEPRAZOLE	L. Perrigo Company	38082e59-c509-4be5-b29c-33a97565df1c	2024-06-27	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 0113-1803
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	0edfa800-fb14-44dd-9c31-de930b864ef9	2024-06-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	76b941f0-a02f-43e8-821e-09ccf675d944	2024-06-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	5ee3cb79-5c0c-456f-b5d5-d5a008bbd118	2024-04-26	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	05fae639-ba68-4c05-8ca7-7c5cc2d50584	2024-04-16	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
Omeprazole	OMEPRAZOLE	Kroger Company	236a9447-23ec-44c7-a241-20f9ddc83ab8	2024-03-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 30142-593
Good Sense Omeprazole	OMEPRAZOLE	L. Perrigo Company	db333c49-2c3e-4ade-a202-7d4499205fc4	2024-03-24	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 0113-1723
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	907e9974-46b8-4dae-be92-518c076cb98f	2024-03-07	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Walgreen Company	b7972f17-4a63-4d78-a181-01ea6d7d3963	2024-03-04	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 0363-0007
foster and thrive omeprazole	OMEPRAZOLE	Strategic Sourcing Services LLC	836efc63-b633-497c-ab56-76bb495bd723	2024-02-20	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	b6c87a6a-253a-4455-9b7d-62f506da592e	2023-08-02	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 41163-915
omeprazole	OMEPRAZOLE	Walgreen Company	87cee50d-4c1e-473d-9d70-b1622f84aee1	2023-03-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 175 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0915	Good Sense Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-0915	Good Sense Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-1723	Good Sense Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-1723	Good Sense Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-1803	good sense omeprazole delayed release	omeprazole	L. Perrigo Company	NDA	Current
0113-7401	Basic Care Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-7401	Basic Care Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-7401	Basic Care Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-7915	Basic Care Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0113-7915	Basic Care Omeprazole	Omeprazole	L. Perrigo Company	NDA	Current
0363-0007	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0363-0007	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0363-0007	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0363-0007	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0363-0007	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0363-0915	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0363-0915	omeprazole	Omeprazole	Walgreen Company	NDA	Current
0904-5834	omeprazole	Omeprazole	Major Pharmaceuticals	NDA	Current
0904-5834	omeprazole	Omeprazole	Major Pharmaceuticals	NDA	Current
10202-915	seven select omeprazole	Omeprazole	7-Eleven	NDA	Current
10202-915	seven select omeprazole	Omeprazole	7-Eleven	NDA	Current
11383-257	Omeprazole	Omeprazole	Weeks & Leo Co., Inc.	NDA	Current
11673-018	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-018	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-018	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-018	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-346	up and up omeprazole	omeprazole	Target Corporation	NDA	Current
11673-915	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-915	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-915	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-915	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11673-915	up and up omeprazole	Omeprazole	Target Corporation	NDA	Current
11822-0453	omeprazole	Omeprazole	Rite Aid Corporation	NDA	Current
11822-0453	omeprazole	Omeprazole	Rite Aid Corporation	NDA	Current
11822-0915	omeprazole	Omeprazole	Rite Aid Corporation	NDA	Current
11822-0915	omeprazole	Omeprazole	Rite Aid Corporation	NDA	Current
11822-0915	omeprazole	Omeprazole	Rite Aid Corporation	NDA	Current
11822-1190	omeprazole	omeprazole	Rite Aid Corporation	NDA	Current
21130-137	Signature Care Omeprazole	Omeprazole	Safeway	NDA	Current
21130-137	Signature Care Omeprazole	Omeprazole	Safeway	NDA	Current
21130-137	Signature Care Omeprazole	Omeprazole	Safeway	NDA	Current
21130-401	signature care omeprazole	omeprazole	Safeway	NDA	Current
21130-401	signature care omeprazole	omeprazole	Safeway	NDA	Current
30142-557	omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-557	omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-557	omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-557	omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-593	Omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-593	Omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-593	Omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-593	Omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-593	Omeprazole	Omeprazole	Kroger Company	NDA	Current
30142-593	Omeprazole	Omeprazole	Kroger Company	NDA	Current
36800-121	TopCare Omeprazole delayed release	Omeprazole	Topco Associates LLC	NDA	Current
36800-121	TopCare Omeprazole delayed release	Omeprazole	Topco Associates LLC	NDA	Current
36800-121	TopCare Omeprazole delayed release	Omeprazole	Topco Associates LLC	NDA	Current
36800-915	TopCare Omeprazole	Omeprazole	Topco Associates LLC	NDA	Current
36800-915	TopCare Omeprazole	Omeprazole	Topco Associates LLC	NDA	Current
36800-915	TopCare Omeprazole	Omeprazole	Topco Associates LLC	NDA	Current
37012-401	Omeprazole	Omeprazole	Shopko Stores Operating Co., LLC	NDA	Current
37012-401	Omeprazole	Omeprazole	Shopko Stores Operating Co., LLC	NDA	Current
37012-915	Omeprazole	Omeprazole	Shopko Stores Operating Co., LLC	NDA	Current
37205-837	leader omeprazole	Omeprazole	Cardinal Health	NDA	Current
37808-401	omeprazole	Omeprazole	H E B	NDA	Current
37808-401	omeprazole	Omeprazole	H E B	NDA	Current
37808-401	omeprazole	Omeprazole	H E B	NDA	Current
37808-915	omeprazole	Omeprazole	H E B	NDA	Current
37808-915	omeprazole	Omeprazole	H E B	NDA	Current
37808-915	omeprazole	Omeprazole	H E B	NDA	Current
37808-915	omeprazole	Omeprazole	H E B	NDA	Current
41163-614	equaline omeprazole delayed release	Omeprazole	Supervalu Inc	NDA	Current
41163-614	equaline omeprazole delayed release	Omeprazole	Supervalu Inc	NDA	Current
41163-915	equaline omeprazole	Omeprazole	Supervalu Inc	NDA	Current
41163-915	equaline omeprazole	Omeprazole	Supervalu Inc	NDA	Current
41190-915	ShopRite Omeprazole	Omeprazole	Wakefern Food Corporation	NDA	Current
41250-401	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-401	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-401	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-401	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-401	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83675	SUPPL	2025-10-07
83665	SUPPL	2025-10-06
81678	SUPPL	2025-03-24
80200	SUPPL	2024-11-12
80199	SUPPL	2024-11-12
72399	SUPPL	2022-10-17
72315	SUPPL	2022-10-13
72252	SUPPL	2022-10-05
72212	SUPPL	2022-10-03
68033	SUPPL	2021-07-08
58277	SUPPL	2019-04-10
58273	SUPPL	2019-04-10
50429	SUPPL	2017-11-15
50411	SUPPL	2017-11-14
50362	SUPPL	2017-11-13
50295	SUPPL	2017-11-06
38112	SUPPL	2016-02-11
6733	SUPPL	2016-02-11
16804	SUPPL	2015-06-19
6732	SUPPL	2015-06-12
38111	SUPPL	2015-03-12
29114	SUPPL	2015-03-10
16803	SUPPL	2014-01-15
38110	SUPPL	2013-09-19
29113	SUPPL	2013-08-20
6731	SUPPL	2012-10-30
6730	SUPPL	2012-09-11
29112	SUPPL	2012-04-11
6729	SUPPL	2011-07-05
29111	SUPPL	2010-07-23
16802	SUPPL	2009-07-24
6728	SUPPL	2009-07-23
44669	ORIG	2009-05-28
21912	ORIG	2009-05-28
29110	SUPPL	2009-04-07
29109	ORIG	2008-01-09
6727	ORIG	2007-07-05