Application 072555
- Type
- ANDA
- Sponsor
- ANDA REPOSITORY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 2MG | No | No |
| 002 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 0.5MG | No | No |
| 003 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 1MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072555-001 | LORAZEPAM | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | ||
| A072555-002 | LORAZEPAM | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | ||
| A072555-003 | LORAZEPAM | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 |
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 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072555-002 | LORAZEPAM | 0.5MG | TABLET / ORAL | 1991-03-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072555-003 | LORAZEPAM | 1MG | TABLET / ORAL | 1991-03-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072555-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1991-03-29 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Lorazepam | LORAZEPAM | PD-Rx Pharmaceuticals, Inc. | 08a30230-fc95-9025-e063-6394a90ae21b | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Rising Pharma Holdings, Inc. | 386255e2-65aa-48ce-9eb1-246f1493cc14 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Preferred Pharmaceuticals, Inc. | 00960fbd-a5da-408b-9867-62982f20906f | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Preferred Pharmaceuticals, Inc. | 6cc1f35d-ff33-404e-aa5e-b01eab89863e | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Ativan | LORAZEPAM | Bausch Health US LLC | 89057c93-8155-4040-acec-64e877bd2b4c | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | LORAZEPAM |
| LOREEV XR | LORAZEPAM | A-S Medication Solutions | c470fdee-8e18-4da9-b072-943d6b2518cf | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 3c20c89f-c8c3-43b3-837e-da413f449795 | 2025-05-27 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 17919c82-87f2-5030-e063-6294a90ac91a | 2025-04-21 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Golden State Medical Supply, Inc. | 32fb5628-bf80-0135-e063-6294a90aa3ab | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 1791d5c9-9004-5c4b-e063-6294a90adf3d | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 8aaf9bcb-7a4e-ffaa-e053-2995a90a3913 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| LORAZEPAM | LORAZEPAM | DirectRx | ddcc0b2b-4be2-6d18-e053-2a95a90af987 | 2025-01-22 | Warnings, Adverse reactions | LORAZEPAM LORAZEPAM |
| Lorazepam | LORAZEPAM | Major Pharmaceuticals | 62f6eb3b-813d-4890-aca9-799b7fa890df | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 4a66b854-4dd6-3746-e054-00144ff8d46c | 2025-01-20 | Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| LORAZEPAM | LORAZEPAM | Advanced Rx of Tennessee, LLC | 2a57e549-390b-5482-e063-6394a90aeb3b | 2024-12-28 | Boxed warning, Warnings, Adverse reactions | LORAZEPAM LORAZEPAM |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 29f63525-2839-946c-e063-6294a90aebb1 | 2024-12-23 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Fresenius Kabi USA, LLC | b2487467-a63f-48b5-b0de-3a6ce6672d50 | 2024-11-26 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 503834f9-fa2e-5e23-e054-00144ff88e88 | 2024-11-13 | Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | A-S Medication Solutions | be85b116-9f09-403a-8e0d-e77e344d3a9a | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Chartwell RX, LLC | 6b0619c5-b9e9-47e7-97b5-7e581e67cf5f | 2024-11-07 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |