Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM |
| 003 | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM |
| 004 | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM |
| 005 | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | KLONOPIN RAPIDLY DISINTEGRATING | CLONAZEPAM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 6 | AP | 2010-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2010-09-01 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 2011-11-29 | N/A |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2016-12-16 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 31 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 7 |
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 20813
[companyName] => ROCHE
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/017533s058lbl.pdf#page=20"]
[products] => [{"drugName":"KLONOPIN RAPIDLY DISINTEGRATING","activeIngredients":"CLONAZEPAM","strength":"0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KLONOPIN RAPIDLY DISINTEGRATING","activeIngredients":"CLONAZEPAM","strength":"0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KLONOPIN RAPIDLY DISINTEGRATING","activeIngredients":"CLONAZEPAM","strength":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KLONOPIN RAPIDLY DISINTEGRATING","activeIngredients":"CLONAZEPAM","strength":"1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KLONOPIN RAPIDLY DISINTEGRATING","activeIngredients":"CLONAZEPAM","strength":"2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/16\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020813s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020813s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-9","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-7","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-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017533s046s048,020813s006s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2010","submission":"SUPPL-6","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017533s046s048,020813s006s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017533s045,020813s005lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"KLONOPIN RAPIDLY DISINTEGRATING","submission":"CLONAZEPAM","actionType":"0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN RAPIDLY DISINTEGRATING","submission":"CLONAZEPAM","actionType":"0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN RAPIDLY DISINTEGRATING","submission":"CLONAZEPAM","actionType":"0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN RAPIDLY DISINTEGRATING","submission":"CLONAZEPAM","actionType":"1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KLONOPIN RAPIDLY DISINTEGRATING","submission":"CLONAZEPAM","actionType":"2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-12-16
)
)