Documents
Application Sponsors
| NDA 014694 | ASPEN GLOBAL INC | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 002 | INJECTABLE;INJECTION | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE |
| 003 | INJECTABLE;INJECTION | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE |
| 004 | INJECTABLE;INJECTION | EQ 20MG PHOSPHATE/ML | 0 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1964-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1981-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1981-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1984-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1985-02-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1987-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1988-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1992-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1994-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1995-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 1995-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2014-07-16 | STANDARD |
Submissions Property Types
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 30 | Null | 7 |
CDER Filings
ASPEN GLOBAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 14694
[companyName] => ASPEN GLOBAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 4MG PHOSPHATE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 10MG PHOSPHATE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HEXADROL","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 20MG PHOSPHATE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/16\/2014","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/014694s030lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HEXADROL","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 4MG PHOSPHATE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HEXADROL","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 10MG PHOSPHATE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HEXADROL","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 20MG PHOSPHATE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2014-07-16
)
)