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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 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… |
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 | A-S Medication Solutions | 28675dd6-b952-4e71-b0a3-b701ad6b6344 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | St Marys Medical Park Pharmacy | 31a7ed52-48a6-1c87-e054-00144ff88e88 | 2025-05-22 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | American Health Packaging | c13297e2-ae3e-4198-b7c8-55fd672436aa | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Coupler LLC | 2e970dc2-cd78-bcdf-e063-6294a90ad3e0 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Coupler LLC | 2cdb55a7-54e4-17b6-e063-6294a90ac827 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Direct_Rx | fc75869c-cd6b-44a3-e053-6294a90a699e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| CLONAZEPAM | CLONAZEPAM | DIRECT RX | a821f647-be5f-274c-e053-2a95a90a23ce | 2025-01-17 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Advanced Rx of Tennessee, LLC | 04db8e8c-38f9-0c4a-e063-6394a90a93f0 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | b9309a1a-a794-2f62-e053-2a95a90a7c34 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | be383e56-d71f-7699-e053-2995a90a50c1 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 263f99eb-9744-5601-e063-6394a90a47b1 | 2024-11-14 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 8891c5aa-f42a-4206-92b9-f0ed0631dfcb | 2024-10-23 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 214e760b-c909-bd93-e063-6294a90ae74a | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | NuCare Pharmaceuticals,Inc. | 555061d4-276a-4716-e054-00144ff88e88 | 2024-10-16 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 66bf60fa-61ac-47a7-a081-36077af9007e | 2024-10-14 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 7b0d716c-8f51-47a7-8bf2-07c6f9732a05 | 2024-09-29 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 20b3125e-4489-3c53-e063-6294a90a6539 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | b12661a6-2141-42a9-bcb0-c0aef81395ce | 2024-08-23 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | b83009c2-26ed-45fa-819e-164cdac264e6 | 2024-08-23 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 96518266-8f75-4301-b8fd-d2995a7f486d | 2024-08-06 | Warnings, Adverse reactions | CLONAZEPAM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |