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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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RAPIDLY DISINTEGRATING | CLONAZEPAM | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 1997-12-23 | |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 | Preferred Pharmaceuticals Inc. | 87f362a7-cf66-4166-af51-ac2da473cf6b | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 939dee35-3987-4ce2-9985-3751ceffa20e | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | b1c53213-9f84-4389-b6dc-3dc26d9a6364 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 00f323c0-e007-40df-ae7f-e6b3c7ba0aa8 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 44f39aa8-a7bc-4e42-977c-31583e6388ae | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | AvPAK | f2662808-01c4-330c-e053-2a95a90aa335 | 2026-02-24 | Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | a4185456-68f9-47d4-9952-fcdef86989db | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 095a80b0-09f9-4bd1-b377-5212d7c966ba | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Northstar Rx LLC | 017534e6-49ff-45f3-b88f-2f34cf0cf8fd | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Klonopin | CLONAZEPAM | H2-Pharma, LLC | cfa0d79a-843c-4b88-95a1-e9511d649ca1 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 9ee4e019-6a99-4aac-84b0-9aae597815a7 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | c707caa1-d6fd-4790-9a64-f749bf93ef18 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 1ce88d2c-70f7-427b-8787-4afd9ce6f71c | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Par Health USA, LLC | 1aef0069-80ea-483d-ac70-c8d485462c5b | 2025-10-06 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 08d0a109-3307-47b5-8ff2-c0ad83e66f08 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 9a74ea97-1c00-4d96-a06f-81c183943dc6 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | ca79f244-7e6e-4612-af26-e6e5cefbd3a2 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Solco Healthcare LLC | 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| CLONAZEPAM | CLONAZEPAM | Alembic Pharmaceuticals Inc. | ecb28fcb-f0d1-4558-b460-ecabd0f6009e | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | CLONAZEPAM |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | dec8b5b2-2490-4880-a8d1-707b57954297 | 2025-06-20 | Boxed warning, 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 |