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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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 | Chartwell RX, LLC | 7b543f77-4388-4227-942f-7933f200b3a5 | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 5f3a2f64-57ed-475c-9d8c-b2094bf1d79e | 2023-10-26 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 5ae98718-9da5-4edc-8efb-67b212577548 | 2023-10-18 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | cc14bb7b-d0c8-4f41-bcd9-a0c860b45a43 | 2023-10-18 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542 | 2023-10-01 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 645fb912-479c-46de-b99c-4ea341bfd9ba | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 6be64dc3-3748-477c-8800-2c2175309c73 | 2023-07-17 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 6960e994-e9ea-4a4a-b674-7e6124d8b381 | 2023-05-25 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Teva Pharmaceuticals USA, Inc. | 8069b1a0-7c06-4252-b44e-e2eef065d9b8 | 2023-04-25 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aurobindo Pharma Limited | b1582eb7-af35-45d5-a52e-0e380d08527d | 2023-02-02 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| CLONAZEPAM | CLONAZEPAM | Alembic Pharmaceuticals Limited | 43ee20ce-0015-413c-b230-822e390b02f7 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 4dcb6785-e16b-4692-89b3-f905979ca5ae | 2022-11-01 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 56175c25-3fde-43ea-89bf-22dcf3278b6b | 2022-11-01 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 63286201-4b79-45b8-8f48-7e21dadc1408 | 2021-02-01 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | c68420a9-b646-4a4f-99f7-43d652312eb0 | 2018-02-14 | 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 |