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Farmers Insurance
Harvard Business School
AstraZeneca
Dow
Cipla
Merck
Argus Health
Moodys
US Army

Generated: May 22, 2018

DrugPatentWatch Database Preview

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. 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 018703
Tradename:ZANTAC 300
Applicant:Glaxo Grp Ltd
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 018703
Suppliers and Packaging for NDA: 018703
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZANTAC 150 ranitidine hydrochloride TABLET;ORAL 018703 NDA GlaxoSmithKline LLC 0173-0393 N 0173-0393-40
ZANTAC 300 ranitidine hydrochloride TABLET;ORAL 018703 NDA GlaxoSmithKline LLC 0173-0393 N 0173-0393-40

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jun 9, 1983TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Dec 9, 1985TE:ABRLD:Yes

Expired US Patents for NDA 018703

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

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
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Deloitte
Cantor Fitzgerald
Daiichi Sankyo
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Healthtrust

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