Zantac

NDA 19675, held by Glaxo Grp Ltd. Ranitidine Hydrochloride.

As of Nov 13, 2026, NDA 19675 (Zantac), held by Glaxo Grp Ltd, was first approved by FDA on Dec 30, 1988, with 29 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1988
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Mar 29, 1995	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 30, 1988	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZantacEQ 15MG BASE/ML · syrup;oral	Ranitidine Hydrochloride	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements


Sep 4, 2009	Supplement 35Labeling · Standard review	Approved	Letter Label
Feb 20, 2009	Supplement 34Labeling · Standard review	Approved	Label Letter
Jul 12, 2006	Supplement 32Labeling · Standard review	Approved	Letter
Apr 28, 2005	Supplement 31Labeling · Standard review	Approved	Letter Label
Apr 30, 2004	Supplement 30Manufacturing · Standard review	Approved	Letter
Sep 24, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 15, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 7, 2002	Supplement 25Labeling · Standard review	Approved	Letter
May 9, 2001	Supplement 24Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 23Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 20Labeling · Standard review	Approved	Letter Review
Oct 22, 1999	Supplement 22Labeling · Standard review	Approved	None posted
Oct 22, 1999	Supplement 21Labeling · Standard review	Approved	None posted
Nov 27, 1996	Supplement 19Labeling · Standard review	Approved	None posted
Mar 29, 1995	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 30, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 3, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Nov 3, 1994	Supplement 13Labeling	Approved	None posted
Feb 28, 1994	Supplement 12Labeling	Approved	None posted
Apr 5, 1993	Supplement 14Labeling	Approved	None posted
Jul 22, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
May 19, 1992	Supplement 9Labeling	Approved	None posted
Nov 25, 1991	Supplement 3Labeling	Approved	None posted
Dec 20, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 12, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 21, 1990	Supplement 7Labeling	Approved	None posted
Jul 16, 1990	Supplement 4Labeling	Approved	None posted
Aug 8, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
May 18, 1989	Supplement 2Labeling	Approved	None posted
Dec 30, 1988	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 19675
Drugs@FDA: Overview at FDA
Company: Glaxo Group

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