Application Sponsors
| NDA 018312 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | 0.02MG | 0 | CALDEROL | CALCIFEDIOL |
| 002 | CAPSULE;ORAL | 0.05MG | 0 | CALDEROL | CALCIFEDIOL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1980-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1984-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-06-16 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1986-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1997-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2000-06-15 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 18312
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"CALDEROL","activeIngredients":"CALCIFEDIOL","strength":"0.02MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CALDEROL","activeIngredients":"CALCIFEDIOL","strength":"0.05MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CALDEROL","submission":"CALCIFEDIOL","actionType":"0.02MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CALDEROL","submission":"CALCIFEDIOL","actionType":"0.05MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)