Zantac 150, Zantac 25

NDA 20251, held by Glaxo Grp Ltd. Ranitidine Hydrochloride.

As of Nov 13, 2026, NDA 20251 (Zantac 150, Zantac 25), held by Glaxo Grp Ltd, was first approved by FDA on Mar 31, 1994, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1994
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
Mar 31, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Zantac 150EQ 150MG BASE · tablet, effervescent;oral	Ranitidine Hydrochloride	Discontinued
Zantac 150EQ 150MG BASE/PACKET · granule, effervescent;oral	Ranitidine Hydrochloride	Discontinued
Zantac 25EQ 25MG BASE · tablet, effervescent;oral	Ranitidine Hydrochloride	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Sep 4, 2009	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 20, 2009	Supplement 18Labeling · Standard review	Approved	Label Letter
Jul 12, 2006	Supplement 17Labeling · Standard review	Approved	Letter
Apr 28, 2005	Supplement 16Labeling · Standard review	Approved	Letter Label
Apr 1, 2004	Supplement 15Manufacturing · Standard review	Approved	Label Letter
Jan 15, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 7, 2002	Supplement 11Labeling · Standard review	Approved	Letter
May 9, 2001	Supplement 10Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 9Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 6Labeling · Standard review	Approved	Letter Review
Oct 22, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Oct 22, 1999	Supplement 7Labeling · Standard review	Approved	None posted
Nov 27, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Mar 29, 1995	Supplement 4Labeling · Standard review	Approved	None posted
Nov 14, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Nov 3, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Mar 31, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20251
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