Application 213593

Type: NDA
Sponsor: AZURITY PAHRMACEUTICALS, INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KONVOMEP	OMEPRAZOLE AND SODIUM BICARBONATE	SUSPENSION;ORAL	2MG; 84MG / ML	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
N213593-001	KONVOMEP	OMEPRAZOLE; SODIUM BICARBONATE	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL		RLD, RS	2022-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213593-001	10751333	2039-07-16		Drug product	2022-10-21
N213593-001	11103492	2039-07-16		Drug product	2022-10-21
N213593-001	11633478	2039-07-16		Drug product	2023-05-12
N213593-001	11911473	2039-07-16	U-623		2024-03-14
N213593-001	11911473	2039-07-16	U-624		2024-03-14
N213593-001	12042539	2039-07-16		Drug product	2024-08-02
N213593-001	12329752	2039-07-16		Drug product	2025-06-18
N213593-001	12440566	2039-07-16		Drug product	2025-10-15
N213593-001	11771686	2040-03-01	U-623		2023-10-30

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213593-001	KONVOMEP	2MG/ML;84MG/ML	FOR SUSPENSION / ORAL	RLD, RS	2022-08-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	12329752	2039-07-16		Drug product	2025-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	12440566	2039-07-16		Drug product	2025-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	12329752	2039-07-16		Drug product	2025-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	12440566	2039-07-16		Drug product	2025-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	12329752	2039-07-16		Drug product	2025-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	10751333	2039-07-16		Drug product	2022-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11103492	2039-07-16		Drug product	2022-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11633478	2039-07-16		Drug product	2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11911473	2039-07-16	U-623		2024-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11911473	2039-07-16	U-624		2024-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	12042539	2039-07-16		Drug product	2024-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213593-001	11771686	2040-03-01	U-623		2023-10-30	`b8a1b40f171c…`

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
Konvomep	OMEPRAZOLE AND SODIUM BICARBONATE	Azurity Pharmaceuticals, Inc.	688ed6f1-d78a-4006-a682-57021cb38a3e	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213593 application number: NDA213593 ndc (product): 65628-272

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65628-272	Konvomep	omeprazole and sodium bicarbonate	Azurity Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75199	ORIG	2023-08-22
71975	ORIG	2022-09-01
71984	ORIG	2022-08-31
71983	ORIG	2022-08-31