Lanoxicaps

NDA 18118, held by Glaxosmithkline LLC. Digoxin.

As of Nov 13, 2026, NDA 18118 (Lanoxicaps), held by Glaxosmithkline LLC, was first approved by FDA on Jul 26, 1982, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1982
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Sep 24, 1984	Supplement 2Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 26, 1982	Original applicationNew dosage form · Standard review	Approved	Review

Products

4 strengths and forms


Lanoxicaps0.2MG · capsule;oral	Digoxin	Discontinued
Lanoxicaps0.05MG · capsule;oral	Digoxin	Discontinued
Lanoxicaps0.1MG · capsule;oral	Digoxin	Discontinued
Lanoxicaps0.15MG · capsule;oral	Digoxin	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Oct 28, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 15, 1998	Supplement 16Labeling · Standard review	Approved	Review
Jun 25, 1996	Supplement 15Labeling · Standard review	Approved	None posted
May 5, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 28, 1994	Supplement 14Labeling · Standard review	Approved	None posted
Aug 6, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
May 7, 1992	Supplement 11Labeling · Standard review	Approved	None posted
Jan 31, 1989	Supplement 10Labeling · Standard review	Approved	None posted
May 22, 1987	Supplement 9Labeling · Standard review	Approved	None posted
Sep 4, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 12, 1986	Supplement 6Labeling · Standard review	Approved	None posted
Aug 12, 1986	Supplement 3Labeling · Standard review	Approved	None posted
Sep 24, 1984	Supplement 2Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 18, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
May 10, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 9, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 5, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 26, 1982	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 18118
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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