Application Sponsors
| ANDA 080399 | ANI PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 0.75MG | 0 | DEXAMETHASONE | DEXAMETHASONE |
| 002 | TABLET;ORAL | 4MG | 0 | DEXAMETHASONE | DEXAMETHASONE |
FDA Submissions
| ORIG | 1 | AP | 1971-10-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1982-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 1982-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 1982-08-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 1983-07-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1984-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 2022-08-15 | UNKNOWN |
Submissions Property Types
| SUPPL | 70 | Null | 0 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 74 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 79 | Null | 15 |
TE Codes
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 80399
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)