Zantac 150, Zantac 300

NDA 20095, held by Glaxosmithkline. Ranitidine Hydrochloride.

As of Nov 13, 2026, NDA 20095 (Zantac 150, Zantac 300), held by Glaxosmithkline, was first approved by FDA on Mar 8, 1994, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 8, 1994
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 8, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Zantac 150EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ranitidine Hydrochloride	DiscontinuedReference drug
Zantac 300EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ranitidine Hydrochloride	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 15, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 7, 2002	Supplement 13Labeling · Standard review	Approved	Letter
May 9, 2001	Supplement 12Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 7Labeling · Standard review	Approved	Letter Review
Oct 29, 1999	Supplement 11Labeling · Standard review	Approved	None posted
Oct 22, 1999	Supplement 9Labeling · Standard review	Approved	None posted
Oct 22, 1999	Supplement 10Labeling · Standard review	Approved	None posted
Sep 12, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 27, 1996	Supplement 6Labeling · Standard review	Approved	Review
Mar 29, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Nov 14, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Nov 3, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Apr 4, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Mar 8, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20095
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