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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 074365

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NDA 074365 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, Cosette, 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 fourteen suppliers. Additional details are available on the CIMETIDINE profile page.

The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are twenty-five 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 074365

Tradename:	CIMETIDINE
Applicant:	Teva
Ingredient:	cimetidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 074365

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	200MG
Approval Date:	Feb 28, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 28, 1995	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Feb 28, 1995	TE:		RLD:	No

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