Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 15MG/VIAL | 1 | IXEMPRA KIT | IXABEPILONE |
| 002 | INJECTABLE;INTRAVENOUS | 45MG/VIAL | 1 | IXEMPRA KIT | IXABEPILONE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2007-10-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2009-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2009-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-05-12 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2011-10-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2015-01-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2016-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-01-21 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2023-01-11 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 31 |
| SUPPL | 13 | Null | 6 |
CDER Filings
R-PHARM US LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 22065
[companyName] => R-PHARM US LLC
[docInserts] => ["",""]
[products] => [{"drugName":"IXEMPRA KIT","activeIngredients":"IXABEPILONE","strength":"15MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"IXEMPRA KIT","activeIngredients":"IXABEPILONE","strength":"45MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/18\/2011","submission":"SUPPL-6","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022065s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2010","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022065s004s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022065s004s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022065s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2009","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022065s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022065s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022065s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022065lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"IXEMPRA KIT","submission":"IXABEPILONE","actionType":"15MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"IXEMPRA KIT","submission":"IXABEPILONE","actionType":"45MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2011-10-18
)
)