Cimetidine

Sold as Tagamet, Tagamet Hb, Tagamet Hb 200. Every FDA application for this active ingredient: 3 branded and 30 generic.

As of Nov 13, 2026, FDA lists 33 applications for Cimetidine (sold as Tagamet, Tagamet Hb, Tagamet Hb 200), first approved Aug 16, 1977, with 13 new uses approved and 0 published complete response letters.

First approved: Aug 16, 1977
Applications: 33
New uses approved: 13
Complete response letters: 0
Medicare spending, 2025: $5.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Cimetidine	Part D	$5.6M	-8%	24,390

Clinical Trials

30 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Neoadjuvant Finotonlimab Plus TP Regimen in Locally Advanced INI-1-Deficient Sinonasal CarcinomaSMARCB1-Deficient Sinonasal Carcinoma · Eye & ENT Hospital of Fudan University	Phase 2	Recruiting	Nov 10, 2026
Hinge vs CCK ImplantsRevision Arthroplasty, Knee · Medstar Health Research Institute	Not applicable	Recruiting	Sep 14, 2026
Zimmer Biomet-RibFix TitanRib Fracture, Rib Fracture Multiple · Zimmer Biomet	—	Recruiting	Mar 20, 2026
Zimmer ActivBraid Rotator Cuff Repair (RCR) StudyRotator Cuff Repair of the Shoulder · The Cleveland Clinic	—	Recruiting	May 14, 2025
Zimmer Biomet Shoulder Arthroplasty PMCF StudyShoulder Fractures, Shoulder Arthritis Osteoarthritis · Zimmer Biomet	—	Recruiting	Apr 9, 2025
Robotic Medial Congruent Vs. Conventional Medial Pivot TKAKnee Osteoarthristis · George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures	Not applicable	Recruiting	Mar 5, 2025
Clinical and Microbiological Outcomes of Dental Implants After 10-22 Years of FunctionPocket Depth, Attachment Loss · Aristotle University Of Thessaloniki	—	Enrolling by invitation	Jan 31, 2025
Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, Osteoarthritis (OA) of the Knee · Vastra Gotaland Region	Not applicable	Active, not recruiting	Dec 6, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 16, 1977	TagametNDA 17920 · New molecular entity	Glaxosmithkline	72	Discontinued
May 17, 1994	CimetidineANDA 74151	Teva	14	Marketed
May 17, 1994	CimetidineANDA 74246	Mylan	8	Marketed
May 17, 1994	CimetidineANDA 74329	Chartwell Molecules	6	Marketed
May 17, 1994	CimetidineANDA 74463	Teva	13	Marketed
Dec 23, 1994	CimetidineANDA 74361	Cycle	1	Discontinued
Dec 23, 1994	CimetidineANDA 74371	Cycle	1	Discontinued
Jan 31, 1995	CimetidineANDA 74100	Chartwell Rx	16	Discontinued
Feb 28, 1995	CimetidineANDA 74365	Teva	21	Discontinued
May 30, 1995	CimetidineANDA 74402	Ivax Sub Teva Pharms	4	Discontinued
May 30, 1995	CimetidineANDA 74401	Ivax Sub Teva Pharms	6	Discontinued
Jun 19, 1995	Tagamet HbNDA 20238 · TYPE 8	Medtech Products	19	Marketed
Jun 23, 1995	CimetidineANDA 74339	Novitium Pharma	3	Discontinued
Jun 23, 1995	CimetidineANDA 74340	Novitium Pharma	3	Discontinued
Jun 29, 1995	CimetidineANDA 74250	Sandoz	16	Discontinued
Jul 28, 1995	CimetidineANDA 74424	Ivax Sub Teva Pharms	14	Discontinued
Jan 24, 1996	CimetidineANDA 74506	Upsher Smith Labs	4	Discontinued
Feb 28, 1996	CimetidineANDA 74316	Watson Labs Inc	1	Discontinued
Aug 30, 1996	CimetidineANDA 74349	Watson Labs Inc	1	Discontinued
Feb 27, 1997	CimetidineANDA 74566	Pliva	2	Discontinued
Feb 27, 1997	CimetidineANDA 74568	Pliva	4	Discontinued
Jun 19, 1998	CimetidineANDA 74963	Contract Pharmacal	1	Discontinued
Jun 19, 1998	CimetidineANDA 74948	Apotex	5	Discontinued
Jun 19, 1998	CimetidineANDA 74961	Contract Pharmacal	5	Discontinued
Jun 19, 1998	CimetidineANDA 74972	Perrigo	0	Discontinued
Jun 19, 1998	CimetidineANDA 75122	Sandoz	5	Discontinued
Oct 29, 1998	CimetidineANDA 75285	L Perrigo Co	8	Marketed
Dec 18, 1998	CimetidineANDA 74890	Hikma	0	Discontinued
Jun 16, 1999	CimetidineANDA 75345	Ivax Sub Teva Pharms	5	Discontinued
Jul 9, 1999	Tagamet Hb 200NDA 20951 · New dosage form	Glaxosmithkline	3	Discontinued
Jul 29, 1999	CimetidineANDA 75425	Watson Labs Teva	0	Discontinued
Nov 7, 2024	CimetidineANDA 218220	Bionpharma	0	Marketed
Nov 12, 2024	CimetidineANDA 218997	Aurobindo Pharma Ltd	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA