Application 075468
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLONAZEPAM | CLONAZEPAM | TABLET;ORAL | 0.5MG | No | No |
| 002 | CLONAZEPAM | CLONAZEPAM | TABLET;ORAL | 1MG | No | No |
| 003 | CLONAZEPAM | CLONAZEPAM | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075468-001 | CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | |
| A075468-002 | CLONAZEPAM | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | |
| A075468-003 | CLONAZEPAM | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | |
| A075468-004 | CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET / ORAL | 2026-06-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075468-001 | AB |
| A075468-002 | AB |
| A075468-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075468-004 | CLONAZEPAM | 0.25MG | TABLET / ORAL | 2026-06-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075468-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2000-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075468-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2000-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075468-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2000-10-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075468-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075468-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075468-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075468-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075468-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075468-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075468-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075468-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075468-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075468-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075468-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075468-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075468-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075468-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075468-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075468-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075468-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075468-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075468-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075468-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075468-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075468-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075468-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075468-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075468-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075468-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075468-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075468-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075468-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075468-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075468-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075468-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075468-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075468-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075468-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075468-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075468-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075468-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075468-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075468-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 19475112-60da-4d53-b330-70afe28ebaf3 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | c4b87c17-efcd-4b66-96e7-159a04c808b5 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 8bb69bbe-07e1-4123-9b70-fde78d1d0a34 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Advagen Pharma Ltd | 30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 72888-154 72888-152 72888-153 |
| Clonazepam | CLONAZEPAM | Unit Dose Solutions, Inc. | 54789918-cc0c-7090-e063-6394a90aeba7 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | f803fefc-69ff-4963-950b-48c13998bc2c | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Northstar Rx LLC | 017534e6-49ff-45f3-b88f-2f34cf0cf8fd | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Coupler LLC | 2e970dc2-cd78-bcdf-e063-6294a90ad3e0 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Coupler LLC | 2cdb55a7-54e4-17b6-e063-6294a90ac827 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 8891c5aa-f42a-4206-92b9-f0ed0631dfcb | 2024-10-23 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
| Clonazepam | CLONAZEPAM | Clinical Solutions Wholesale, LLC | 401cb3c0-4a5b-4ff9-baea-53095e60263d | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | 075468 ANDA075468 |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30897 | ORIG | 2000-10-06 |