Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019734
Company: CHIESI USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDENE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE;INTRAVENOUS Prescription None Yes Yes
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE;INTRAVENOUS Prescription None Yes Yes
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE;INTRAVENOUS Prescription None Yes Yes
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE;INTRAVENOUS Discontinued None Yes 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
01/30/1992 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2018 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019734s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019734Orig1s030Ltr.pdf
08/26/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019734s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019734Orig1s027ltr.pdf
12/21/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/21/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/02/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/23/2014 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019734Orig1s023ltr.pdf
04/30/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/02/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019734s017ltr.pdf
01/13/2010 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019734s015ltr.pdf
11/07/2008 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s014ltr.pdf
07/31/2008 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s013ltr.pdf
06/22/2007 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019734s009ltr.pdf
10/24/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/20/1992 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/27/2018 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019734s030lbl.pdf
08/26/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019734s027lbl.pdf
07/23/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf
02/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf
01/13/2010 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf

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