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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009330
Company: COVIS

Products on NDA 009330

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009330

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
11/02/2022	SUPPL-36	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009330Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/009330Orig1s036ltr.pdf
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.

Labels for NDA 009330

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009330Orig1s036lbl.pdf
11/02/2022	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009330Orig1s036lbl.pdf
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

Therapeutic Equivalents for NDA 009330

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
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

LANOXIN PEDIATRIC

There are no Therapeutic Equivalents.

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