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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020405
Company: ADVANZ PHARMA

Products on NDA 020405

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	AB	Yes	No
LANOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	AB	Yes	No
LANOXIN	DIGOXIN	0.1875MG	TABLET;ORAL	Discontinued	None	Yes	No
LANOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	AB	Yes	Yes
LANOXIN	DIGOXIN	0.375MG	TABLET;ORAL	Discontinued	None	No	No
LANOXIN	DIGOXIN	0.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020405

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1997	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020405_lanoxin_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2024	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020405Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020405Orig1s017ltr.pdf
02/22/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020405s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020405Orig1s015ltr.pdf
08/24/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020405s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020405Orig1s014ltr.pdf
12/01/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020405s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020405Orig1s013ltr.pdf
09/03/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/28/2015	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020405Orig1s011ltr.pdf
11/22/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/21/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/17/2013	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020405Orig1s007ltr.pdf
11/14/2011	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020405s006ltr.pdf
08/13/2012	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020405Orig1s005ltr.pdf
02/05/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020405s004ltr.pdf
12/07/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/19/1999	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020405

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2024	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020405Orig1s017lbl.pdf
02/22/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020405s015lbl.pdf
08/24/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020405s14lbl.pdf
12/01/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020405s013lbl.pdf
07/28/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf
10/17/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf
08/13/2012	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf
11/14/2011	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf
02/05/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf

Therapeutic Equivalents for NDA 020405

LANOXIN

TABLET;ORAL; 0.0625MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	No	AB	214982	AUROBINDO PHARMA LTD
DIGOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	No	AB	215307	NOVITIUM PHARMA
LANOXIN	DIGOXIN	0.0625MG	TABLET;ORAL	Prescription	Yes	AB	020405	ADVANZ PHARMA

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	214982	AUROBINDO PHARMA LTD
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	077002	HIKMA INTL PHARMS
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	215307	NOVITIUM PHARMA
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	040282	RISING
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	No	AB	076268	STEVENS J
LANOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	Yes	AB	020405	ADVANZ PHARMA

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	214982	AUROBINDO PHARMA LTD
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	077002	HIKMA INTL PHARMS
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	215307	NOVITIUM PHARMA
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	040282	RISING
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	No	AB	076268	STEVENS J
LANOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	Yes	AB	020405	ADVANZ PHARMA

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