Questran Light

NDA 19669, held by Bristol Myers. Cholestyramine.

As of Nov 13, 2026, NDA 19669 (Questran Light), held by Bristol Myers, was first approved by FDA on Dec 5, 1988, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 5, 1988
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 5, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Questran LightEQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;oral	Cholestyramine	DiscontinuedReference drug
Questran LightEQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;oral	Cholestyramine	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 20, 2000	Supplement 24Labeling · Standard review	Approved	None posted
Oct 29, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 22, 1997	Supplement 22Labeling · Standard review	Approved	None posted
Sep 22, 1995	Supplement 18Labeling · Standard review	Approved	None posted
Sep 22, 1995	Supplement 17Labeling · Standard review	Approved	None posted
Dec 12, 1994	Supplement 19Labeling · Standard review	Approved	None posted
Jan 7, 1993	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 22, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 11, 1992	Supplement 15Labeling · Standard review	Approved	None posted
Sep 10, 1991	Supplement 12Labeling · Standard review	Approved	None posted
Mar 12, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 2, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 27, 1989	Supplement 7Labeling · Standard review	Approved	None posted
Feb 21, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 21, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 21, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 5, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19669
Drugs@FDA: Overview at FDA
Company: Bristol Myers

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