Documents
Application Sponsors
| NDA 021024 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 150MG | 1 | PRIFTIN | RIFAPENTINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1998-06-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-07-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-12-10 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-09-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2000-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-12-12 | |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2009-06-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2010-07-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 10 | AP | 2014-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2014-11-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2015-08-07 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2015-07-01 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2020-06-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 25 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 5 | Null | 41 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 14 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 31 |
| SUPPL | 20 | Null | 7 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21024
[companyName] => SANOFI AVENTIS US
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021024s017s018lbl.pdf#page=28"]
[products] => [{"drugName":"PRIFTIN","activeIngredients":"RIFAPENTINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/05\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021024s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021024s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021024s017s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021024s013lbl.pdf\"}]","notes":"Please see"},{"actionDate":"11\/25\/2014","submission":"SUPPL-11","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021024s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2010","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021024s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2009","submission":"SUPPL-8","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021024s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2000","submission":"SUPPL-5","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/21024s5_Priftin_prntlbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/21024lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PRIFTIN","submission":"RIFAPENTINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-06-05
)
)