Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022276
Company: EXELA PHARMA SCIENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE;INJECTION Prescription None No No
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE;INTRAVENOUS Discontinued None 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
07/24/2008 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/2008/022276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022276s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s011ltr.pdf
10/28/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/07/2016 SUPPL-8 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s008ltr.pdf
01/10/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/08/2009 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022276s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/23/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf
04/07/2016 SUPPL-8 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf
01/08/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf
07/24/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf

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