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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021606
Company: ABBVIE

Products on NDA 021606

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ZEMPLAR	PARICALCITOL	4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021606

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/2011/021606s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021606s009(1)ltr.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-Container/Carton Labels, Labeling-Package Insert		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

Labels for NDA 021606

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

Therapeutic Equivalents for NDA 021606

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
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	091412	DR REDDYS
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	204948	MARKSANS PHARMA
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	202124	RISING
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
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	091412	DR REDDYS
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	204948	MARKSANS PHARMA
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	202124	RISING
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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