Documents
Application Sponsors
| NDA 019616 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 004 | TABLET;ORAL | 200MG | 0 | PENETREX | ENOXACIN |
| 005 | TABLET;ORAL | 400MG | 0 | PENETREX | ENOXACIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1991-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1997-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1996-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2002-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2002-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-04-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 19616
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"PENETREX","activeIngredients":"ENOXACIN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENETREX","activeIngredients":"ENOXACIN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PENETREX","submission":"ENOXACIN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENETREX","submission":"ENOXACIN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)