Application 071195
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071195-001 | LORAZEPAM | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A071195-001 | LORAZEPAM | 2MG | TABLET / ORAL | 1988-04-15 | f41ea6bd6efb… |
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 | A-S Medication Solutions | 8602cef8-167e-4a8c-b10f-fc3295a3abcc | 2024-01-21 | Boxed warning, Warnings, Adverse reactions | LORAZEPAM LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 973eff80-b2cd-42ca-8e88-e0151e691e59 | 2024-01-19 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Clinical Solutions Wholesale, LLC | fdc11b95-2233-42b4-b5f3-9390b5e9e1b2 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 0ce02d7d-d855-c73f-e063-6294a90abe93 | 2023-12-19 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Leading Pharma, LLC | 5ca13415-4b77-4131-a9d2-6db26bc49167 | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Asclemed USA, Inc. | 91da80c8-3162-43f0-b53e-897070b26a54 | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| LORAZEPAM | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 247110f2-5468-4593-8d86-41f8c869e03d | 2023-10-17 | Boxed warning, Warnings, Adverse reactions | LORAZEPAM LORAZEPAM |
| Lorazepam | LORAZEPAM | Chartwell RX, LLC | e075c78d-f0c6-4380-b769-bb8833d23ba5 | 2023-09-01 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| LORAZEPAM | LORAZEPAM | A-S Medication Solutions | 823b1d71-a510-4d34-8015-60b55af23d78 | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | LORAZEPAM LORAZEPAM |
| Lorazepam | LORAZEPAM | Amneal Pharmaceuticals LLC | bf265c2e-ab2f-42e5-96cf-3998eb5a644d | 2023-07-28 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | SUN PHARMACEUTICAL INDUSTRIES INC | 0c1caa9c-9ef1-459c-86c3-adb939130a9f | 2023-06-30 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Teva Pharmaceuticals USA, Inc. | 1bf22e97-9425-484d-bac6-519c6bae6a37 | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Proficient Rx LP | a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569 | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 8df3eed3-c936-4772-ab08-574c54dd8bf5 | 2023-01-04 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Pharmaceutical Associates, Inc. | 711b60a3-028d-41d4-aa17-8f976e6df23e | 2022-08-11 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Proficient Rx LP | 73bf2b31-5c7e-4b3a-9e97-8304931510b0 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Proficient Rx LP | 5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Hikma Pharmaceuticals USA Inc. | b79b38ee-c29d-4099-964f-000031f47f5a | 2022-04-26 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 1c956cc1-9217-46e0-80a3-7c811163d3f1 | 2021-09-30 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
| Lorazepam | LORAZEPAM | Civica, Inc. | 5140798d-8571-41fb-84a4-e182aac3f64c | 2021-04-27 | Boxed warning, Warnings, Adverse reactions | Lorazepam LORAZEPAM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.