Application 214826
- Type
- NDA
- Sponsor
- Almatica Pharma, LLC
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-001 | LOREEV XR | 1MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-002 | LOREEV XR | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2021-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-003 | LOREEV XR | 3MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2021-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-004 | LOREEV XR | 1.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2022-02-16 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-001 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-002 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-003 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214826-004 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2022-04-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-001 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-002 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-003 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214826-004 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2022-04-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-001 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-002 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-003 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2021-09-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N214826-004 | 8999393 | 2034-01-08 | U-3210 | Drug product | 2022-04-21 | d06236e962d9… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LOREEV XR | LORAZEPAM | Almatica Pharma LLC | 227734c1-bf01-9607-73ea-5a1f38a89bd9 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 214826 NDA214826 52427-667 52427-663 52427-661 52427-658 |
| LOREEV XR | LORAZEPAM | A-S Medication Solutions | c470fdee-8e18-4da9-b072-943d6b2518cf | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | 214826 NDA214826 |
NDC Listings For This Application#
| 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 |