Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | CAPSULE;ORAL | 1MCG | 1 | ZEMPLAR | PARICALCITOL |
| 002 | CAPSULE;ORAL | 2MCG | 1 | ZEMPLAR | PARICALCITOL |
| 003 | CAPSULE;ORAL | 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEMPLAR | PARICALCITOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-05-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2009-06-29 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2007-07-17 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2008-06-18 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2010-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2011-04-06 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2012-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2014-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2013-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2014-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2015-08-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2016-10-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2016-10-18 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 6 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 21606
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"ZEMPLAR","activeIngredients":"PARICALCITOL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZEMPLAR","activeIngredients":"PARICALCITOL","strength":"2MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZEMPLAR","activeIngredients":"PARICALCITOL","strength":"4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/18\/2016","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021606s016s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2016","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021606s016s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021606s012s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021606s012s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2011","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021606s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021606s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2009","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021606s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021606lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZEMPLAR","submission":"PARICALCITOL","actionType":"1MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZEMPLAR","submission":"PARICALCITOL","actionType":"2MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZEMPLAR","submission":"PARICALCITOL","actionType":"4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-10-18
)
)