Application 078203
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 0.5MG | No | No |
| 002 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 1MG | No | No |
| 003 | 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 |
|---|---|---|---|---|---|---|---|
| A078203-001 | LORAZEPAM | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | |
| A078203-002 | LORAZEPAM | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | |
| A078203-003 | LORAZEPAM | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078203-001 | AB |
| A078203-002 | AB |
| A078203-003 | AB |
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 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078203-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078203-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078203-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078203-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078203-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078203-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-001 | AB | 1 | 301d65b070ca… |
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 | Aphena Pharma Solutions - Tennessee, LLC | e563594e-212c-4f31-92ea-294aeab45df3 | 2024-04-12 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | ba34ddd2-9a47-48bf-8e55-f05e9085e5a8 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | 8e3d44fb-24b7-4552-9e95-de3bf871a88b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 973eff80-b2cd-42ca-8e88-e0151e691e59 | 2024-01-19 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Clinical Solutions Wholesale, LLC | fdc11b95-2233-42b4-b5f3-9390b5e9e1b2 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 58118-1095 58118-1096 58118-0904 |
| Lorazepam | LORAZEPAM | Leading Pharma, LLC | 5ca13415-4b77-4131-a9d2-6db26bc49167 | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Asclemed USA, Inc. | 91da80c8-3162-43f0-b53e-897070b26a54 | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 8df3eed3-c936-4772-ab08-574c54dd8bf5 | 2023-01-04 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Proficient Rx LP | 73bf2b31-5c7e-4b3a-9e97-8304931510b0 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | e83ae439-3fa5-453f-9073-4bf8c797df47 | 2019-03-26 | Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75 | 2018-11-05 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8075 | Lorazepam | Lorazepam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8075 | Lorazepam | Lorazepam | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8076 | Lorazepam | Lorazepam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8076 | Lorazepam | Lorazepam | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8077 | Lorazepam | Lorazepam | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8077 | Lorazepam | Lorazepam | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0904-6007 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6007 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6007 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6008 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6008 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6008 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6009 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6009 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6009 | Lorazepam | Lorazepam | Major Pharmaceuticals | ANDA | Current |
| 10544-269 | Lorazepam | Lorazepam | Blenheim Pharmacal, Inc. | ANDA | Current |
| 17856-2059 | Lorazepam | Lorazepam | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-2059 | Lorazepam | Lorazepam | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 33261-068 | Lorazepam | Lorazepam | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-069 | Lorazepam | Lorazepam | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-364 | Lorazepam | Lorazepam | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-096 | Lorazepam | Lorazepam | Rebel Distributors Corp | ANDA | Current |
| 42254-111 | Lorazepam | Lorazepam | Rebel Distributors Corp | ANDA | Current |
| 42254-113 | Lorazepam | Lorazepam | Rebel Distributors Corp | ANDA | Current |
| 43353-255 | Lorazepam | Lorazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2810 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 50090-3510 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 50090-5081 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 50090-5508 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 50090-5508 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 50090-5509 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 50090-5509 | Lorazepam | Lorazepam | A-S Medication Solutions | ANDA | Current |
| 53002-5291 | Lorazepam | Lorazepam | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5291 | Lorazepam | Lorazepam | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-6290 | Lorazepam | Lorazepam | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-6290 | Lorazepam | Lorazepam | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7721 | Lorazepam | Lorazepam | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-208 | Lorazepam | Lorazepam | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-216 | Lorazepam | Lorazepam | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 54348-049 | Lorazepam | LORAZEPAM | PharmPak, Inc. | ANDA | Current |
| 54348-049 | Lorazepam | LORAZEPAM | PharmPak, Inc. | ANDA | Current |
| 55154-7975 | Lorazepam | Lorazepam | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7975 | Lorazepam | Lorazepam | Cardinal Health | ANDA | Current |
| 55154-7976 | Lorazepam | Lorazepam | Cardinal Health | ANDA | Current |
| 55154-7976 | Lorazepam | Lorazepam | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7976 | Lorazepam | Lorazepam | Cardinal Health | ANDA | Current |
| 55154-7977 | Lorazepam | Lorazepam | Cardinal Health 107, LLC | ANDA | Current |
| 55700-614 | Lorazepam | Lorazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-745 | Lorazepam | Lorazepam | Quality Care Products, LLC | ANDA | Current |
| 55700-778 | Lorazepam | Lorazepam | Quality Care Products, LLC | ANDA | Current |
| 55700-778 | Lorazepam | Lorazepam | Quality Care Products, LLC | ANDA | Current |
| 58118-0904 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0904 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0904 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1095 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1095 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1095 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1096 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1096 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1096 | Lorazepam | Lorazepam | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-516 | Lorazepam | Lorazepam | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-516 | Lorazepam | Lorazepam | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-062 | LORAZEPAM | LORAZEPAM | DIRECT RX | ANDA | Current |
| 61919-062 | Lorazepam | Lorazepam | Direct_Rx | ANDA | Current |
| 61919-062 | Lorazepam | Lorazepam | Direct_Rx | ANDA | Current |
| 61919-062 | Lorazepam | Lorazepam | Direct_Rx | ANDA | Current |
| 61919-062 | LORAZEPAM | LORAZEPAM | DIRECT RX | ANDA | Current |
| 61919-062 | LORAZEPAM | LORAZEPAM | DIRECT RX | ANDA | Current |
| 61919-062 | Lorazepam | Lorazepam | Direct_Rx | ANDA | Current |
| 61919-143 | LORAZEPAM | LORAZEPAM | DIRECTRX | ANDA | Current |
| 61919-607 | LORAZEPAM | LORAZEPAM | DirectRX | ANDA | Current |
| 61919-607 | LORAZEPAM | LORAZEPAM | DirectRX | ANDA | Current |
| 61919-607 | LORAZEPAM | LORAZEPAM | DirectRX | ANDA | Current |
| 61919-607 | LORAZEPAM | LORAZEPAM | DirectRX | ANDA | Current |
| 63739-802 | Lorazepam | Lorazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-802 | Lorazepam | Lorazepam | McKesson Corporation | ANDA | Current |
| 63739-803 | Lorazepam | Lorazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-803 | Lorazepam | Lorazepam | McKesson Corporation | ANDA | Current |
| 63739-804 | Lorazepam | Lorazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-804 | Lorazepam | Lorazepam | McKesson Corporation | ANDA | Current |