Application Sponsors
| ANDA 085261 | ANI PHARMS INC | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 004 |
Application Products
| 002 | TABLET;ORAL | 200MG | 0 | AMINOPHYLLINE | AMINOPHYLLINE |
| 004 | TABLET;ORAL | 100MG | 0 | AMINOPHYLLINE | AMINOPHYLLINE |
FDA Submissions
| ORIG | 1 | AP | 1976-12-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1981-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1981-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1982-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1982-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1984-02-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1984-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1984-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1987-06-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1987-06-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1987-06-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1987-06-19 | |
| LABELING; Labeling | SUPPL | 54 | AP | 1989-11-30 | |
| LABELING; Labeling | SUPPL | 55 | AP | 1989-11-30 | |
| LABELING; Labeling | SUPPL | 56 | AP | 1990-12-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1995-01-06 | |
Submissions Property Types
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 57 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 85261
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOPHYLLINE","activeIngredients":"AMINOPHYLLINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOPHYLLINE","activeIngredients":"AMINOPHYLLINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINOPHYLLINE","submission":"AMINOPHYLLINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOPHYLLINE","submission":"AMINOPHYLLINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)