Drugs@FDA: FDA Approved Drug Products

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

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 INC
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 PHARMA BV

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