Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020095

« Back to Dashboard

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-three 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
Therapeutic Class:	Gastrointestinal Agents
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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994	➤ Sign Up	➤ Sign Up
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994	➤ Sign Up	➤ Sign Up
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	➤ Sign Up	➤ Sign Up
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.