Application 022056

Type: NDA
Sponsor: COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRILOSEC	OMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 2.5MG BASE/PACKET	Yes	No
002	PRILOSEC	OMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 10MG BASE/PACKET	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022056-001	PRILOSEC	OMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2008-03-20
N022056-002	PRILOSEC	OMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2008-03-20

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 3 · 86 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	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`74a2ff9319b5…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022056-001	6428810	2019-11-03	U-1817	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022056-001	6428810	2019-11-03	U-864	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022056-002	6428810	2019-11-03	U-864	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022056-001	6428810	2019-11-03	U-1817	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022056-001	6428810	2019-11-03	U-864	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022056-002	6428810	2019-11-03	U-864	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022056-001	6428810	2019-11-03	U-1817	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022056-001	6428810	2019-11-03	U-864	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022056-002	6428810	2019-11-03	U-864	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022056-001	6428810	2019-11-03	U-1817	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022056-001	6428810	2019-11-03	U-864	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022056-002	6428810	2019-11-03	U-864	Drug product	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prilosec	OMEPRAZOLE MAGNESIUM	Covis Pharma US, Inc	b6761f84-53ac-4745-a8c8-1e5427d7e179	2024-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022056 application number: NDA022056 ndc (product): 70515-610 ndc (product): 70515-625

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 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0610	PRILOSEC	Omeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0625	PRILOSEC	Omeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
66993-426	Omeprazole magnesium	omeprazole magnesium	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-427	Omeprazole magnesium	omeprazole magnesium	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70515-610	Prilosec	omeprazole magnesium	Covis Pharma	NDA	Current
70515-610	Prilosec	omeprazole magnesium	Covis Pharma	NDA	Current
70515-610	Prilosec	omeprazole magnesium	Covis Pharma US, Inc	NDA	Current
70515-610	Prilosec	omeprazole magnesium	Covis Pharma	NDA	Current
70515-610	Prilosec	omeprazole magnesium	Covis Pharma US, Inc	NDA	Current
70515-625	Prilosec	omeprazole magnesium	Covis Pharma	NDA	Current
70515-625	Prilosec	omeprazole magnesium	Covis Pharma	NDA	Current
70515-625	Prilosec	omeprazole magnesium	Covis Pharma US, Inc	NDA	Current
70515-625	Prilosec	omeprazole magnesium	Covis Pharma	NDA	Current
70515-625	Prilosec	omeprazole magnesium	Covis Pharma US, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74818	SUPPL	2023-07-20
74817	SUPPL	2023-07-20
74780	SUPPL	2023-07-19
70472	SUPPL	2022-03-10
70471	SUPPL	2022-03-10
70427	SUPPL	2022-03-07
70426	SUPPL	2022-03-07
65400	SUPPL	2020-11-30
65399	SUPPL	2020-11-30
65386	SUPPL	2020-11-30
55460	SUPPL	2018-09-12
55459	SUPPL	2018-09-12
55318	SUPPL	2018-08-24
55297	SUPPL	2018-08-24
55296	SUPPL	2018-08-24
54583	SUPPL	2018-06-14
54523	SUPPL	2018-06-11
46477	SUPPL	2016-12-22
46491	SUPPL	2016-12-21
45715	SUPPL	2016-10-31
45657	SUPPL	2016-10-26
38155	SUPPL	2016-02-11
6784	SUPPL	2016-02-04
38154	SUPPL	2014-12-29
6783	SUPPL	2014-12-24
29165	SUPPL	2014-04-14
16857	SUPPL	2014-04-01
29166	SUPPL	2014-02-27
16858	SUPPL	2014-02-27
38153	SUPPL	2013-05-21
6782	SUPPL	2013-05-16
16855	SUPPL	2012-10-12
29164	SUPPL	2012-10-11
6781	SUPPL	2012-10-02
16856	SUPPL	2012-10-01
16854	SUPPL	2012-02-06
29163	SUPPL	2012-01-24
23695	ORIG	2011-12-20
38150	SUPPL	2011-07-06
6778	SUPPL	2011-07-06
38152	SUPPL	2011-05-25
6780	SUPPL	2011-05-25
6779	SUPPL	2011-01-25
38151	SUPPL	2011-01-24
16853	SUPPL	2010-09-10
6777	SUPPL	2010-09-08
42403	ORIG	2010-03-16
24237	ORIG	2010-03-16
29162	SUPPL	2010-03-08
38149	SUPPL	2010-03-05
16852	SUPPL	2008-12-04
6776	SUPPL	2008-12-04
29161	ORIG	2008-03-24
16851	ORIG	2008-03-24
68836	ORIG	1900-01-01
67205	ORIG	1900-01-01
67204	ORIG	1900-01-01
67069	ORIG	1900-01-01
67068	ORIG	1900-01-01
51452	SUPPL	1900-01-01
51450	SUPPL	1900-01-01