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Details for New Drug Application (NDA): 020095

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NDA 020095 describes ZANTAC 300, which is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the ZANTAC 300 profile page.

The generic ingredient in ZANTAC 300 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-five suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 020095

Tradename:	ZANTAC 300
Applicant:	Glaxosmithkline
Ingredient:	ranitidine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:	Mar 8, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:	Mar 8, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020095

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994

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