Application Sponsors
ANDA 085202 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | TABLET;ORAL | 100MG | 0 | SLO-PHYLLIN | THEOPHYLLINE |
FDA Submissions
| ORIG | 1 | AP | 1979-11-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-07-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-07-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1982-07-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-07-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1983-03-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-07-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-01-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1984-07-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1985-11-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1990-06-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-06-18 | |
LABELING; Labeling | SUPPL | 20 | AP | 1990-07-26 | |
LABELING; Labeling | SUPPL | 21 | AP | 1990-11-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-04-29 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 24 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 85202
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"SLO-PHYLLIN","activeIngredients":"THEOPHYLLINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SLO-PHYLLIN","submission":"THEOPHYLLINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)