Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021648
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIGOXIN DIGOXIN 0.05MG/ML ELIXIR;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/26/2004 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21648lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21648ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021648s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021648s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021648Orig1s011ltr.pdf
12/01/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021648s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021648Orig1s009ltr.pdf
07/28/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021648Orig1s008ltr.pdf
07/03/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/27/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021648s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021648Orig1s006ltr.pdf
11/18/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s005ltr.pdf
09/26/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021648Orig1REVs004.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/24/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021648s011lbl.pdf
12/01/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021648s009lbl.pdf
07/28/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf
09/27/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021648s006lbl.pdf
11/18/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s005lbl.pdf
09/26/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s004lbl.pdf
08/26/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21648lbl.pdf

DIGOXIN

ELIXIR;ORAL; 0.05MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIGOXIN DIGOXIN 0.05MG/ML ELIXIR;ORAL Prescription Yes AA 021648 HIKMA
DIGOXIN DIGOXIN 0.05MG/ML ELIXIR;ORAL Prescription No AA 213000 NOVITIUM PHARMA

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