Application Sponsors
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 50MG | 1 | HEXALEN | ALTRETAMINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1990-12-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-01-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-04-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-01-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-09-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1991-10-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-03-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1992-05-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 1993-02-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-03-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-07-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-06-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-07-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-10-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-07-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2013-02-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2014-01-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2014-08-29 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 7 | Null | 14 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 9 | Null | 14 |
| SUPPL | 11 | Null | 14 |
| SUPPL | 12 | Null | 14 |
| SUPPL | 13 | Null | 14 |
| SUPPL | 14 | Null | 14 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Null | 14 |
| SUPPL | 17 | Null | 14 |
| SUPPL | 23 | Null | 14 |
| SUPPL | 24 | Null | 14 |
| SUPPL | 25 | Null | 14 |
CDER Filings
EISAI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19926
[companyName] => EISAI INC
[docInserts] => ["",""]
[products] => [{"drugName":"HEXALEN","activeIngredients":"ALTRETAMINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HEXALEN","submission":"ALTRETAMINE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)