Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021606
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZEMPLAR | PARICALCITOL | 1MCG | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ZEMPLAR | PARICALCITOL | 2MCG | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ZEMPLAR | PARICALCITOL | 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/18/2016 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf | |
| 10/18/2016 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf | |
| 08/29/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf | |
| 08/29/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf | |
| 04/06/2011 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021606s009lbl.pdf | |
| 06/11/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021606s007lbl.pdf | |
| 06/29/2009 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021606s004lbl.pdf | |
| 05/26/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021606lbl.pdf |