Application Sponsors
| ANDA 086944 | ANI PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | DIPYRIDAMOLE | DIPYRIDAMOLE |
| 002 | TABLET;ORAL | 25MG | 0 | DIPYRIDAMOLE | DIPYRIDAMOLE |
| 003 | TABLET;ORAL | 75MG | 0 | DIPYRIDAMOLE | DIPYRIDAMOLE |
FDA Submissions
| ORIG | 1 | AP | 1991-04-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1982-03-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1982-03-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1982-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1982-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1982-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1985-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1983-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1984-08-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1985-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1986-05-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1986-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1986-11-20 | |
| BIOEQUIV; Bioequivalence | SUPPL | 30 | AP | 1989-04-26 | |
| LABELING; Labeling | SUPPL | 31 | AP | 1991-04-16 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1989-11-20 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1992-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1995-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2001-05-09 | |
Submissions Property Types
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 86944
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)