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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201657
Company: HOSPIRA

Products on NDA 201657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PARICALCITOL	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201657s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201657Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/201657Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201657s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201657Orig1s006ltr.pdf
01/11/2017	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/14/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/24/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201657

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201657s006lbl.pdf
10/21/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201657s000lbl.pdf

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