Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040481
Company: SANDOZ

Products on ANDA 040481

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIGOXIN	DIGOXIN	0.25MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040481

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/16/2020	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/02/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/02/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/27/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/18/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040481

DIGOXIN

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