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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201657
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION;INTRAVENOUS Prescription AP No 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
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.cfm
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.

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

PARICALCITOL

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 201657 HOSPIRA
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; 0.005MG/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 201657 HOSPIRA
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; 0.01MG/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 201657 HOSPIRA
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
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