Digoxin

ANDA 84386, held by Wyeth Ayerst. Digoxin.

As of Nov 13, 2026, ANDA 84386 (Digoxin), held by Wyeth Ayerst, was first approved by FDA on Jul 12, 1976, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 12, 1976
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 12, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Digoxin0.25MG/ML · injectable;injection	Digoxin	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 25, 1998	Supplement 12Labeling	Approved	None posted
Mar 10, 1993	Supplement 11Labeling	Approved	None posted
Feb 15, 1991	Supplement 9Labeling	Approved	None posted
Mar 12, 1987	Supplement 6Manufacturing	Approved	None posted
Nov 30, 1984	Supplement 4Manufacturing	Approved	None posted
Jul 12, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84386
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters