Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021606
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEMPLAR PARICALCITOL 1MCG CAPSULE;ORAL Prescription AB Yes No
ZEMPLAR PARICALCITOL 2MCG CAPSULE;ORAL Prescription AB Yes No
ZEMPLAR PARICALCITOL 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/26/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021606lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021606ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021606s000TOC.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021606Orig1s016,s017ltr.pdf
10/18/2016 SUPPL-16 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021606Orig1s016,s017ltr.pdf
08/18/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/29/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021606Orig1s012,s014ltr.pdf
10/17/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/29/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021606s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021606Orig1s012,s014ltr.pdf
06/28/2012 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/06/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021606s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021606s009(1)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021606s009ltr.pdf
06/11/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021606s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021606s007ltr.pdf
06/18/2008 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

07/17/2007 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/29/2009 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021606s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021606s004ltr.pdf
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

ZEMPLAR

CAPSULE;ORAL; 1MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 204327 AMNEAL PHARMS
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 207672 AUROBINDO PHARMA LTD
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 202539 BIONPHARMA INC
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 091412 DR REDDYS LABS LTD
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 206710 LOTUS PHARM CO LTD
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 204948 MARKSANS PHARMA
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 202124 RISING PHARMS
PARICALCITOL PARICALCITOL 1MCG CAPSULE;ORAL Prescription No AB 090829 TEVA PHARMS USA
ZEMPLAR PARICALCITOL 1MCG CAPSULE;ORAL Prescription Yes AB 021606 ABBVIE

CAPSULE;ORAL; 2MCG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 204327 AMNEAL PHARMS
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 207672 AUROBINDO PHARMA LTD
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 202539 BIONPHARMA INC
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 091412 DR REDDYS LABS LTD
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 206710 LOTUS PHARM CO LTD
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 204948 MARKSANS PHARMA
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 202124 RISING PHARMS
PARICALCITOL PARICALCITOL 2MCG CAPSULE;ORAL Prescription No AB 090829 TEVA PHARMS USA
ZEMPLAR PARICALCITOL 2MCG CAPSULE;ORAL Prescription Yes AB 021606 ABBVIE

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