Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Discontinued | 005 |
| Discontinued | 006 |
Application Products
| 001 | TABLET;ORAL | 0.5MG | 1 | KLONOPIN | CLONAZEPAM |
| 002 | TABLET;ORAL | 1MG | 1 | KLONOPIN | CLONAZEPAM |
| 003 | TABLET;ORAL | 2MG | 1 | KLONOPIN | CLONAZEPAM |
| 005 | TABLET;ORAL | 0.125MG | 0 | KLONOPIN | CLONAZEPAM |
| 006 | TABLET;ORAL | 0.25MG | 0 | KLONOPIN | CLONAZEPAM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1975-06-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1975-06-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1978-08-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1979-03-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1979-09-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1981-02-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1980-06-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1981-01-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1983-12-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-12-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 1985-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-05-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1990-07-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 1990-07-19 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1993-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1993-05-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1993-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1993-06-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1993-06-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1994-07-01 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 1997-04-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-06-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-08-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-10-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-11-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1997-03-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-09-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1997-12-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 2001-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1999-10-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-03-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2001-01-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2001-09-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2001-11-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 2002-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2002-03-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2002-03-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 45 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 46 | AP | 2010-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2010-09-01 | UNKNOWN |
| REMS; REMS | SUPPL | 52 | AP | 2011-11-29 | N/A |
| LABELING; Labeling | SUPPL | 53 | AP | 2013-10-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2015-02-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 55 | AP | 2016-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2016-06-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2016-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2017-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2021-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2023-01-13 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 48 | Null | 31 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 15 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 58 | Null | 7 |
| SUPPL | 59 | Null | 7 |
| SUPPL | 61 | Null | 7 |
| SUPPL | 62 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 17533
[companyName] => ROCHE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/017533s059lbl.pdf#page=19"]
[products] => [{"drugName":"KLONOPIN","activeIngredients":"CLONAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KLONOPIN","activeIngredients":"CLONAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"KLONOPIN","activeIngredients":"CLONAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KLONOPIN","activeIngredients":"CLONAZEPAM","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KLONOPIN","activeIngredients":"CLONAZEPAM","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-59","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017533s059lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2017","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017533s059lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017533s058lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-58","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017533s058lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2016","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017533s055lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2016","submission":"SUPPL-55","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017533s055lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017533s053,020813s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2010","submission":"SUPPL-48","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017533s046s048,020813s006s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2010","submission":"SUPPL-46","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017533s046s048,020813s006s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2010","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017533s046s048,020813s006s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017533s045,020813s005lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"KLONOPIN","submission":"CLONAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN","submission":"CLONAZEPAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN","submission":"CLONAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN","submission":"CLONAZEPAM","actionType":"0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KLONOPIN","submission":"CLONAZEPAM","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2017-10-25
)
)