Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020819
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
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
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 207692 AKORN
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 205982 AUROBINDO PHARMA LTD
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 205917 HIKMA PHARMS
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 201657 HOSPIRA INC
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203897 MYLAN LABS LTD
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 091108 SANDOZ INC
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 205982 AUROBINDO PHARMA LTD
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 205917 HIKMA PHARMS
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 201657 HOSPIRA INC
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203897 MYLAN LABS LTD
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 091108 SANDOZ INC
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 205982 AUROBINDO PHARMA LTD
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 205917 HIKMA PHARMS
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 201657 HOSPIRA INC
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203897 MYLAN LABS LTD
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 091108 SANDOZ INC
ZEMPLAR PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020819 ABBVIE

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