Application Sponsors
ANDA 089540 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 125MG | 0 | SLO-BID | THEOPHYLLINE |
FDA Submissions
| ORIG | 1 | AP | 1989-05-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1989-07-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1990-05-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1990-05-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1990-05-30 | |
LABELING; Labeling | SUPPL | 6 | AP | 1990-08-10 | |
LABELING; Labeling | SUPPL | 7 | AP | 1990-11-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-03-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-12-01 | |
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 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 89540
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"SLO-BID","activeIngredients":"THEOPHYLLINE","strength":"125MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SLO-BID","submission":"THEOPHYLLINE","actionType":"125MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)