Darbid

NDA 10744, held by Glaxosmithkline. Isopropamide Iodide.

As of Nov 13, 2026, NDA 10744 (Darbid), held by Glaxosmithkline, was first approved by FDA on Oct 9, 1957, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 9, 1957
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 9, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DarbidEQ 5MG BASE · tablet;oral	Isopropamide Iodide	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2007	Supplement 10Labeling	Approved	None posted
Dec 7, 2007	Supplement 11Labeling	Approved	None posted
Dec 7, 2007	Supplement 12Labeling	Approved	None posted
Dec 7, 2007	Supplement 13Labeling	Approved	None posted
Dec 7, 2007	Supplement 15Labeling	Approved	None posted
Dec 7, 2007	Supplement 16Labeling	Approved	None posted
Dec 7, 2007	Supplement 19Labeling	Approved	None posted
Sep 9, 1988	Supplement 21Labeling	Approved	None posted
Mar 2, 1988	Supplement 18Labeling	Approved	None posted
May 15, 1986	Supplement 17Manufacturing · Standard review	Approved	None posted
May 15, 1986	Supplement 20Labeling	Approved	None posted
Oct 9, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10744
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