Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076268
Company: STEVENS J

Products on ANDA 76268

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIGOXIN	DIGOXIN	0.125MG	TABLET;ORAL	Prescription	AB	No	No
DIGOXIN	DIGOXIN	0.25MG	TABLET;ORAL	Prescription	AB	No	No

Labels for ANDA 076268

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76268_Digoxin_Prntlbl.pdf