Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 80MG/15ML | 0 | THEOLAIR | THEOPHYLLINE |
FDA Submissions
| ORIG | 1 | AP | 1979-03-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-06-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-06-18 | |
LABELING; Labeling | SUPPL | 6 | AP | 1991-06-12 | |
LABELING; Labeling | SUPPL | 8 | AP | 1996-09-20 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
CDER Filings
3M
cder:Array
(
[0] => Array
(
[ApplNo] => 86107
[companyName] => 3M
[docInserts] => ["",""]
[products] => [{"drugName":"THEOLAIR","activeIngredients":"THEOPHYLLINE","strength":"80MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"THEOLAIR","submission":"THEOPHYLLINE","actionType":"80MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)