Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CALCIJEX | CALCITRIOL |
| 002 | INJECTABLE;INJECTION | 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CALCIJEX | CALCITRIOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1986-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1990-04-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-10-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-01-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 1996-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1997-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1997-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-05-26 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1999-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-09-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-05-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2001-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2007-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2012-03-09 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 8 |
| SUPPL | 22 | Null | 7 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 18874
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"CALCIJEX","activeIngredients":"CALCITRIOL","strength":"0.001MG\/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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy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":"CALCIJEX","activeIngredients":"CALCITRIOL","strength":"0.002MG\/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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/09\/2012","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018874s022lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CALCIJEX","submission":"CALCITRIOL","actionType":"0.001MG\/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":"CALCIJEX","submission":"CALCITRIOL","actionType":"0.002MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-03-09
)
)