Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Prescription | 007 |
| Discontinued | 008 |
Application Products
| 001 | CAPSULE;ORAL | 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TRANXENE | CLORAZEPATE DIPOTASSIUM |
| 002 | CAPSULE;ORAL | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TRANXENE | CLORAZEPATE DIPOTASSIUM |
| 003 | CAPSULE;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TRANXENE | CLORAZEPATE DIPOTASSIUM |
| 004 | TABLET;ORAL | 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TRANXENE SD | CLORAZEPATE DIPOTASSIUM |
| 005 | TABLET;ORAL | 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TRANXENE SD | CLORAZEPATE DIPOTASSIUM |
| 006 | TABLET;ORAL | 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TRANXENE | CLORAZEPATE DIPOTASSIUM |
| 007 | TABLET;ORAL | 7.5MG | 1 | TRANXENE | CLORAZEPATE DIPOTASSIUM |
| 008 | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TRANXENE | CLORAZEPATE DIPOTASSIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1972-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1975-03-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1975-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1975-11-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1975-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1976-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1976-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1976-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1977-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1976-05-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1980-03-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1976-12-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1977-01-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1976-12-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1977-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1979-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 1977-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1978-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1978-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1978-12-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1979-06-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1979-06-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1979-06-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1979-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1979-05-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 1981-01-29 | |
| LABELING; Labeling | SUPPL | 40 | AP | 1979-12-12 | |
| LABELING; Labeling | SUPPL | 43 | AP | 1980-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1980-09-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1980-10-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1984-02-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1986-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1985-08-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1986-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1986-11-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1987-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1987-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2002-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1987-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2002-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1988-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1996-11-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1999-08-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1998-05-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 2002-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2003-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 76 | AP | 2010-06-07 | STANDARD |
| REMS; REMS | SUPPL | 77 | AP | 2011-07-19 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 2015-02-03 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2016-12-16 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 84 | AP | 2021-02-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 85 | AP | 2023-01-13 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 76 | Null | 6 |
| SUPPL | 77 | Null | 6 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 15 |
| SUPPL | 84 | Null | 15 |
| SUPPL | 85 | Null | 6 |
TE Codes
CDER Filings
RECORDATI RARE
cder:Array
(
[0] => Array
(
[ApplNo] => 17105
[companyName] => RECORDATI RARE
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/017105s079lbl.pdf#page=10"]
[products] => [{"drugName":"TRANXENE","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANXENE","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANXENE","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANXENE","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANXENE","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TRANXENE","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TRANXENE SD","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANXENE SD","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/16\/2016","submission":"SUPPL-79","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017105s079lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017105s079lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2010","submission":"SUPPL-76","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017105s076lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2010","submission":"SUPPL-76","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017105s076lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-75","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017105s075lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TRANXENE","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANXENE","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANXENE","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANXENE","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANXENE","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TRANXENE","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TRANXENE SD","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANXENE SD","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2016-12-16
)
)