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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 018703

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NDA 018703 describes ZANTAC 300, which is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in two NDAs. 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. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 018703

Tradename:	ZANTAC 300
Applicant:	Glaxo Grp Ltd
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 9, 1983	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 9, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 018703

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983	⤷ Subscribe	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	⤷ Subscribe	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	⤷ Subscribe	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	⤷ Subscribe	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983	⤷ Subscribe	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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