Tagamet Hb

NDA 20238, held by Medtech Products. Cimetidine.

As of Nov 13, 2026, NDA 20238 (Tagamet Hb), held by Medtech Products, was first approved by FDA on Jun 19, 1995, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1995
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Jun 5, 1998	Supplement 6Efficacy (new indication or use)	Approved	None posted
Nov 15, 1995	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jun 19, 1995	Original applicationTYPE 8 · Standard review	Approved	None posted

Products

2 strengths and forms


Tagamet Hb100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cimetidine	DiscontinuedReference drug
Tagamet Hb200MG · tablet;oral	Cimetidine	OTCReference drug

All 20 submissions, including labeling and manufacturing supplements


May 24, 2022	Supplement 26Manufacturing	Approved	Label Letter
Mar 15, 2021	Supplement 25Manufacturing	Approved	Label Letter
Apr 13, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Mar 26, 2019	Supplement 23Labeling · Standard review	Approved	Letter Label
Sep 26, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 6, 2008	Supplement 17Labeling · Standard review	Approved	Letter
Oct 4, 2006	Supplement 15Manufacturing · Standard review	Approved	Letter
May 10, 2005	Supplement 13Labeling · Standard review	Approved	Review Letter Label
Aug 11, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
May 14, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 10, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 6, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 5, 1998	Supplement 6Efficacy (new indication or use)	Approved	None posted
Mar 5, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 15, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 21, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 23, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 29, 1996	Supplement 3Labeling · Standard review	Approved	None posted
Nov 15, 1995	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jun 19, 1995	Original applicationTYPE 8 · Standard review	Approved	None posted

Identifiers

Application: NDA 20238
Drugs@FDA: Overview at FDA
Company: Medtech Products

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