Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207174
Company: ACCORD HLTHCARE
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
02/04/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207174s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207174Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/04/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207174s000lbl.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 205982 AUROBINDO PHARMA LTD
PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204910 DR REDDYS LABS LTD
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; 0.005MG/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 LABS LTD
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; 0.01MG/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 LABS LTD
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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