Application 020813
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | TABLET, ORALLY DISINTEGRATING;ORAL | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |
| N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |
| N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |
| N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |
| N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 |
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 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020813-001 | KLONOPIN RAPIDLY DISINTEGRATING | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020813-002 | KLONOPIN RAPIDLY DISINTEGRATING | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020813-003 | KLONOPIN RAPIDLY DISINTEGRATING | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020813-004 | KLONOPIN RAPIDLY DISINTEGRATING | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020813-005 | KLONOPIN RAPIDLY DISINTEGRATING | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | 2680178bc6a6… |
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 | REMEDYREPACK INC. | 64bb2cdf-f57d-4a41-a5bf-ee77b6e64d06 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 19475112-60da-4d53-b330-70afe28ebaf3 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | c4b87c17-efcd-4b66-96e7-159a04c808b5 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 8bb69bbe-07e1-4123-9b70-fde78d1d0a34 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 874b0395-fecb-446a-966f-6ecbb23f1ff6 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Advagen Pharma Ltd | 30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Coupler LLC | 54d6e348-4c51-221e-e063-6294a90a9b7d | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 533a12a8-64fb-494f-a2a4-da1515ef1908 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Unit Dose Solutions, Inc. | 54789918-cc0c-7090-e063-6394a90aeba7 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 1fb0807c-dccd-47a5-ada4-91418c4f47f5 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | f613573a-3e8b-4abf-af69-0268f3d6f481 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Major Pharmaceuticals | 34366dd2-432c-4fa9-8fab-832cca781b84 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| clonazepam | CLONAZEPAM | Advagen Pharma Ltd | 19fc756c-72fe-4504-beaa-4fa2235af18c | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Coupler LLC | 511216c7-6878-f90a-e063-6394a90aaac8 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Cardinal Health 107, LLC | 5ad315f2-fa09-4956-b931-f9966fb73e4e | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 2fe0d214-9c4d-4a0c-9024-c2076c092c1a | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | f803fefc-69ff-4963-950b-48c13998bc2c | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 87f362a7-cf66-4166-af51-ac2da473cf6b | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46628 | SUPPL | 2016-12-30 |
| 46461 | SUPPL | 2016-12-22 |
| 46283 | SUPPL | 2016-12-20 |
| 3406 | SUPPL | 2013-11-06 |
| 35396 | SUPPL | 2013-11-01 |
| 25886 | SUPPL | 2011-12-05 |
| 3405 | SUPPL | 2010-09-21 |
| 3404 | SUPPL | 2010-09-21 |
| 35395 | SUPPL | 2010-09-07 |
| 13470 | SUPPL | 2010-09-07 |
| 13469 | SUPPL | 2009-05-12 |
| 25885 | SUPPL | 2009-05-01 |