Details for New Drug Application (NDA): 074251

NDA 074251 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by Hospira, Luitpold, Ph Health, Teva Parenteral, Ani Pharms, Chartwell Molecular, Cycle, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-one NDAs. It is available from three suppliers. Additional details are available on the CIMETIDINE HYDROCHLORIDE profile page.

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

Summary for 074251

Tradename:	CIMETIDINE HYDROCHLORIDE
Applicant:	Chartwell Molecular
Ingredient:	cimetidine hydrochloride
Patents:	0

Pharmacology for NDA: 074251

Mechanism of Action

Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 074251

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074251	ANDA	Chartwell RX, LLC	62135-809	62135-809-24	2 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05)
CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074251	ANDA	Chartwell RX, LLC	62135-809	62135-809-37	237 mL in 1 BOTTLE (62135-809-37)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 300MG BASE/5ML
Approval Date:	Dec 22, 1994	TE:	AA	RLD:	No

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