Last Updated: September 24, 2026

Details for New Drug Application (NDA): 074316

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NDA 074316 describes CIMETIDINE, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecules, Chartwell Rx, Contract Pharmacal, Cycle, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Novitium Pharma, Perrigo, Pliva, Sandoz, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Hospira, Luitpold, Ph Health, Teva Parenteral, Ani Pharms, Chartwell Molecular, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in fifty-one NDAs. It is available from sixteen suppliers. Additional details are available on the CIMETIDINE profile page.

The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for 074316

Tradename:	CIMETIDINE
Applicant:	Watson Labs Inc
Ingredient:	cimetidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 074316

Anti-Ulcer Agents
Cytochrome P-450 CYP1A2 Inhibitors
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Feb 28, 1996	TE:		RLD:	No

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