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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/17/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20819lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20819ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20819_Zemplar.cfm |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020819Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020819Orig1s038ltr.pdf | |
| 05/12/2021 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020819Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020819Orig1s037ltr.pdf | |
| 03/02/2021 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020819Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020819Orig1s036ltr.pdf | |
| 11/30/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020819s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020819Orig1s030ltr.pdf | |
| 04/06/2011 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020819s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s025ltr.pdf | |
| 02/01/2011 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020819s024ltr.pdf |
| 08/20/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020819s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020819s021ltr.pdf | |
| 09/02/2005 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020819s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020819s015ltr.pdf | |
| 03/31/2004 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20819se5-014_zemplar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20819se5-014ltr.pdf | |
| 12/06/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/2003 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf |
| 01/25/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2002 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/24/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20819slr007,011ltr.pdf |
| 02/01/2000 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/18/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20819S3LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20819S3LTR.PDF |
| 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 |
ZEMPLAR
SOLUTION;INTRAVENOUS; 0.005MG/ML (0.005MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207174 | ACCORD HLTHCARE |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206699 | AMNEAL PHARMS CO |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204910 | DR REDDYS |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205982 | EUGIA PHARMA |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205917 | HIKMA PHARMS |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203897 | RISING |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 091108 | SANDOZ |
| ZEMPLAR | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020819 | ABBVIE |
SOLUTION;INTRAVENOUS; 0.002MG/ML (0.002MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207174 | ACCORD HLTHCARE |
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206699 | AMNEAL PHARMS CO |
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204910 | DR REDDYS |
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205982 | EUGIA PHARMA |
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205917 | HIKMA PHARMS |
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 091108 | SANDOZ |
| ZEMPLAR | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020819 | ABBVIE |
SOLUTION;INTRAVENOUS; 0.01MG/2ML (0.005MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207174 | ACCORD HLTHCARE |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206699 | AMNEAL PHARMS CO |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204910 | DR REDDYS |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205982 | EUGIA PHARMA |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205917 | HIKMA PHARMS |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203897 | RISING |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 091108 | SANDOZ |
| ZEMPLAR | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020819 | ABBVIE |