Application Sponsors
ANDA 061884 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 150MG;300MG | 0 | RIFAMATE | ISONIAZID; RIFAMPIN |
FDA Submissions
| ORIG | 1 | AP | 1975-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-12-09 | |
LABELING; Labeling | SUPPL | 10 | AP | 1999-08-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-08-19 | |
LABELING; Labeling | SUPPL | 15 | AP | 2013-07-22 | |
LABELING; Labeling | SUPPL | 17 | AP | 2013-07-22 | |
LABELING; Labeling | SUPPL | 18 | AP | 2019-09-27 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2019-09-27 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2019-09-27 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2019-09-27 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2019-09-27 | STANDARD |
Submissions Property Types
SUPPL | 9 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 15 | Null | 15 |
SUPPL | 17 | Null | 15 |
SUPPL | 18 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 20 | Null | 7 |
SUPPL | 22 | Null | 7 |
SUPPL | 25 | Null | 15 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 61884
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"RIFAMATE","activeIngredients":"ISONIAZID; RIFAMPIN","strength":"150MG;300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RIFAMATE","submission":"ISONIAZID; RIFAMPIN","actionType":"150MG;300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)