Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020819
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZEMPLAR | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| ZEMPLAR | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| ZEMPLAR | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/20/2022 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020819Orig1s038lbl.pdf | |
| 05/12/2021 | SUPPL-37 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020819Orig1s037lbl.pdf | |
| 03/02/2021 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020819Orig1s036lbl.pdf | |
| 11/21/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020819s030lbl.pdf | |
| 04/06/2011 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020819s025lbl.pdf | |
| 08/20/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020819s021lbl.pdf | |
| 09/02/2005 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020819s015lbl.pdf | |
| 03/31/2004 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20819se5-014_zemplar_lbl.pdf | |
| 02/02/2000 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20819S3LBL.PDF | |
| 04/17/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20819lbl.pdf |