Application Sponsors
| ANDA 088269 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | 0 | SLO-BID | THEOPHYLLINE |
FDA Submissions
| ORIG | 1 | AP | 1985-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-04-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1987-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1988-01-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-03-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1988-01-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1989-06-07 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1989-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1989-06-07 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1988-10-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1990-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1990-03-27 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1990-06-21 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1990-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-03-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1998-12-01 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 34 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 88269
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"SLO-BID","activeIngredients":"THEOPHYLLINE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SLO-BID","submission":"THEOPHYLLINE","actionType":"50MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)