Application Sponsors
| ANDA 088481 | FERA PHARMS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 6MG | 0 | DEXAMETHASONE | DEXAMETHASONE |
| 002 | TABLET;ORAL | 0.5MG | 0 | DEXAMETHASONE | DEXAMETHASONE |
| 003 | TABLET;ORAL | 0.75MG | 0 | DEXAMETHASONE | DEXAMETHASONE |
| 004 | TABLET;ORAL | 4MG | 0 | DEXAMETHASONE | DEXAMETHASONE |
FDA Submissions
| ORIG | 1 | AP | 1983-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1984-03-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-05-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1986-05-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-09-16 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1989-07-31 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1990-01-23 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1990-09-18 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1992-04-29 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1994-04-28 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1995-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1997-08-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1997-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-12-06 | |
| LABELING; Labeling | SUPPL | 22 | AP | 2008-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2022-01-14 | UNKNOWN |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 27 | Null | 7 |
TE Codes
| 001 | Prescription | BP |
| 002 | Prescription | BP |
| 003 | Prescription | BP |
| 004 | Prescription | BP |
CDER Filings
ALVOGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 88481
[companyName] => ALVOGEN
[docInserts] => ["",""]
[products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)