Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009330
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANOXIN DIGOXIN 0.25MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
LANOXIN PEDIATRIC DIGOXIN 0.1MG/ML INJECTABLE;INJECTION Prescription None 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
11/16/1954 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/2018 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009330s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009330Orig1s034ltr.pdf
09/20/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009330s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/009330Orig1s033ltr.pdf
12/01/2016 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009330s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009330Orig1s031ltr.pdf
07/28/2015 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009330s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009330Orig1s030ltr.pdf
05/16/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009330s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009330Orig1s027ltr.pdf
11/14/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009330s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009330s026ltr.pdf
02/05/2010 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009330s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009330s025ltr.pdf
06/17/2002 SUPPL-21 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9330s021ltr.pdf
07/15/1998 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/9330-s020_lanoxin.pdf
06/25/1996 SUPPL-18 Labeling

Label is not available on this site.

08/30/1995 SUPPL-17 Labeling

Label is not available on this site.

08/06/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1992 SUPPL-15 Labeling

Label is not available on this site.

09/06/1991 SUPPL-14 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
09/20/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009330s033lbl.pdf
08/24/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009330s034lbl.pdf
12/01/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009330s031lbl.pdf
07/28/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009330s030lbl.pdf
05/16/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009330s027lbl.pdf
11/14/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009330s026lbl.pdf
02/05/2010 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009330s025lbl.pdf

LANOXIN

INJECTABLE;INJECTION; 0.25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIGOXIN DIGOXIN 0.25MG/ML INJECTABLE;INJECTION Prescription No AP 040481 SANDOZ INC
DIGOXIN DIGOXIN 0.25MG/ML INJECTABLE;INJECTION Prescription No AP 083391 WEST-WARD PHARMS INT
LANOXIN DIGOXIN 0.25MG/ML INJECTABLE;INJECTION Prescription Yes AP 009330 COVIS PHARMA BV

LANOXIN PEDIATRIC

There are no Therapeutic Equivalents.

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