Application Sponsors
| ANDA 062303 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 150MG | 0 | RIFADIN | RIFAMPIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1981-07-15 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1992-07-24 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1992-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1994-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-10-23 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
TE Codes
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 62303
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"RIFADIN","activeIngredients":"RIFAMPIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RIFADIN","submission":"RIFAMPIN","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)