Application 214826

Type: NDA
Sponsor: Almatica Pharma, LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOREEV XR	LORAZEPAM	CAPSULE, EXTENDED RELEASE;ORAL	1MG	No	No
002	LOREEV XR	LORAZEPAM	CAPSULE, EXTENDED RELEASE;ORAL	2MG	No	No
003	LOREEV XR	LORAZEPAM	CAPSULE, EXTENDED RELEASE; ORAL	3MG	No	No
004	LOREEV XR	LORAZEPAM	CAPSULE, EXTENDED RELEASE;ORAL	1.5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214826-001	LOREEV XR	LORAZEPAM	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27
N214826-002	LOREEV XR	LORAZEPAM	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27
N214826-003	LOREEV XR	LORAZEPAM	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27
N214826-004	LOREEV XR	LORAZEPAM	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22
N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22
N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22
N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21

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 4 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-01-26 05:58 UTC	2023-01	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`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
2026-10-15 13:18:30	2026-09	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`2680178bc6a6…`

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
LOREEV XR	LORAZEPAM	A-S Medication Solutions	c470fdee-8e18-4da9-b072-943d6b2518cf	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214826 application number: NDA214826

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52427-658	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current
52427-658	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current
52427-661	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current
52427-663	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current
52427-663	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current
52427-667	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current
52427-667	LOREEV XR	lorazepam	Almatica Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73278	ORIG	2023-01-23
73229	SUPPL	2023-01-17
73228	SUPPL	2023-01-17
73194	SUPPL	2023-01-17
71475	ORIG	2022-06-29
68497	ORIG	2021-08-31