Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078556
Company: IMPAX LABS

Products on ANDA 078556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Discontinued	None	No	No
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2009	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
02/09/2026	SUPPL-26	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/12/2020	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
11/12/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
11/12/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/12/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/26/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.