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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`c2088c7a36db…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`c2088c7a36db…`
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…`

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 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
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
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
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 ndc (product): 68196-915
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 ndc (product): 46122-281
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	05fae639-ba68-4c05-8ca7-7c5cc2d50584	2024-04-16	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032 ndc (product): 56062-401
Omeprazole	OMEPRAZOLE	Kroger Company	236a9447-23ec-44c7-a241-20f9ddc83ab8	2024-03-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
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
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
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
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 2 of 3 · 175 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
41250-806	Omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-806	Omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-915	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-915	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41250-915	omeprazole	Omeprazole	Meijer Distribution Inc	NDA	Current
41520-802	careone omeprazole	Omeprazole	American Sales Company	NDA	Current
41520-915	care one omeprazole	Omeprazole	American Sales Company	NDA	Current
41520-915	care one omeprazole	Omeprazole	American Sales Company	NDA	Current
45802-888	omeprazole	Omeprazole	Perrigo New York Inc	NDA	Current
45802-888	omeprazole	Omeprazole	Padagis Israel Pharmaceuticals Ltd	NDA	Current
45802-888	omeprazole	Omeprazole	Perrigo New York Inc	NDA	Current
46122-029	good neighbor pharmacy omeprazole	Omeprazole	Amerisource Bergen	NDA	Current
46122-029	good neighbor pharmacy omeprazole	Omeprazole	Amerisource Bergen	NDA	Current
46122-029	good neighbor pharmacy omeprazole	Omeprazole	Amerisource Bergen	NDA	Current
46122-281	good neighbor pharmacy omeprazole	Omeprazole	Amerisource Bergen	NDA	Current
46122-281	good neighbor pharmacy omeprazole	Omeprazole	Amerisource Bergen	NDA	Current
46994-915	being well omeprazole	Omeprazole	Save-A-Lot Food Stores Ltd	NDA	Current
46994-915	being well omeprazole	Omeprazole	Save-A-Lot Food Stores Ltd	NDA	Current
46994-915	being well omeprazole	Omeprazole	Save-A-Lot Food Stores Ltd	NDA	Current
49035-119	equate omeprazole	Omeprazole	Wal-Mart Stores Inc	NDA	Current
49035-119	equate omeprazole	Omeprazole	Wal-Mart Stores Inc	NDA	Current
49035-119	equate omeprazole	Omeprazole	Wal-Mart Stores Inc	NDA	Current
49035-119	equate omeprazole	Omeprazole	Wal-Mart Stores Inc	NDA	Current
49035-915	Equate omeprazole delayed release	Omeprazole	Wal-Mart Stores Inc	NDA	Current
49035-915	Equate omeprazole delayed release	Omeprazole	Wal-Mart Stores Inc	NDA	Current
49348-846	sunmark omeprazole	Omeprazole	McKesson	NDA	Current
49348-846	sunmark omeprazole	Omeprazole	McKesson	NDA	Current
49348-846	sunmark omeprazole	Omeprazole	Strategic Sourcing Services LLC	NDA	Current
49348-846	sunmark omeprazole	Omeprazole	Strategic Sourcing Services LLC	NDA	Current
49738-915	smart sense omeprazole	Omeprazole	Kmart Corporation	NDA	Current
50066-915	Genozol	Omeprazole	Genomma Lab USA, Inc.	NDA	Current
50594-011	Sound Body Omeprazole	Omeprazole	Big Lots Stores, Inc.	NDA	Current
50594-011	Sound Body Omeprazole	Omeprazole	Big Lots Stores, Inc.	NDA	Current
55301-915	exchange select omeprazole	Omeprazole	Army & Air Force Exchange Service	NDA	Current
55301-915	exchange select omeprazole	Omeprazole	Army & Air Force Exchange Service	NDA	Current
55316-915	healthy accents omeprazole	Omeprazole	DZA Brands LLC	NDA	Current
55319-915	Family Wellness Omeprazole	Omeprazole	Family Dollar Services Inc	NDA	Current
55910-215	dg health omeprazole	Omeprazole	Dolgencorp, LLC	NDA	Current
55910-215	dg health omeprazole	Omeprazole	Dolgencorp, LLC	NDA	Current
55910-215	dg health omeprazole	Omeprazole	Dolgencorp, LLC	NDA	Current
55910-712	dg health omeprazole	omeprazole	Dolgencorp Inc	NDA	Current
55910-915	dg health omeprazole	Omeprazole	Dolgencorp, LLC	NDA	Current
55910-915	dg health omeprazole	Omeprazole	Dolgencorp, LLC	NDA	Current
55910-915	dg health omeprazole	Omeprazole	Dolgencorp, LLC	NDA	Current
56062-401	omeprazole	Omeprazole	Publix Super Markets Inc	NDA	Current
56062-915	omeprazole	Omeprazole	Publix Super Markets Inc	NDA	Current
56062-915	omeprazole	Omeprazole	Publix Super Markets Inc	NDA	Current
57896-760	Omeprazole	Omeprazole	Gericare Pharmaceuticals	NDA	Current
59640-047	omeprazole	omeprazole	H E B	NDA	Current
59779-503	omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
59779-503	omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
59779-503	omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
59779-580	Omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
59779-580	Omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
59779-580	Omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
59779-580	Omeprazole	Omeprazole	CVS Pharmacy	NDA	Current
61715-151	Preferred Plus Omeprazole	Omeprazole	Kinray	NDA	Current
62011-0157	health mart omeprazole	Omeprazole	Strategic Sourcing Services LLC	NDA	Current
62011-0157	health mart omeprazole	Omeprazole	McKesson	NDA	Current
62011-0157	health mart omeprazole	Omeprazole	Strategic Sourcing Services LLC	NDA	Current
62011-0157	health mart omeprazole	Omeprazole	McKesson	NDA	Current
63868-170	QUALITY CHOICE OMEPRAZOLE	omeprazole	Chain Drug Marketing Association	NDA	Current
63940-242	Core Values Omeprazole	Omeprazole	Harmon Stores Inc.	NDA	Current
63940-242	Core Values Omeprazole	Omeprazole	Harmon Stores Inc.	NDA	Current
63940-915	harmon face values omeprazole	Omeprazole	Harmon Stores Inc.	NDA	Current
63981-915	kirkland signature omeprazole	Omeprazole	Costco Wholesale Company	NDA	Current
63981-915	kirkland signature omeprazole	Omeprazole	Costco Wholesale Company	NDA	Current
64024-915	welby omeprazole	Omeprazole	Aldi Inc	NDA	Current
64024-915	welby omeprazole	Omeprazole	Aldi Inc	NDA	Current
64024-915	welby omeprazole	Omeprazole	Aldi Inc	NDA	Current
64861-303	Omeprazole	Omeprazole	Dexcel Ltd.	NDA	Current
68196-915	members mark omeprazole	Omeprazole	Sam's West Inc	NDA	Current
68196-915	members mark omeprazole	Omeprazole	Sam's West Inc	NDA	Current
68391-915	Berkley and Jensen Omeprazole	Omeprazole	BJWC	NDA	Current
68391-915	Berkley and Jensen Omeprazole	Omeprazole	BJWC	NDA	Current
69256-915	Harris Teeter Omeprazole	Omeprazole	Harris Teeter, LLC	NDA	Current
69256-915	Harris Teeter Omeprazole	Omeprazole	Harris Teeter, LLC	NDA	Current
69842-661	Omeprazole	omeprazole	CVS Pharmacy	NDA	Current
70000-0356	leader omeprazole	Omeprazole	Cardinal Health	NDA	Current
70518-0537	omeprazole	Omeprazole	REMEDYREPACK 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