Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083391
Company: WEST-WARD PHARMS INT
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
10/24/1975 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
01/10/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-25 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/22/2000 SUPPL-20 Labeling

Label is not available on this site.

11/25/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/28/1998 SUPPL-18 Labeling

Label is not available on this site.

04/13/1993 SUPPL-17 Labeling

Label is not available on this site.

01/31/1992 SUPPL-16 Labeling

Label is not available on this site.

09/23/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/18/1991 SUPPL-14 Labeling

Label is not available on this site.

10/29/1990 SUPPL-13 Labeling

Label is not available on this site.

07/26/1989 SUPPL-12 Labeling

Label is not available on this site.

09/23/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/13/1982 SUPPL-7 Manufacturing (CMC)

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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