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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Colorcon
Moodys
Fish and Richardson
Daiichi Sankyo
Merck
Express Scripts
Accenture
AstraZeneca

Generated: May 28, 2018

DrugPatentWatch Database Preview

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-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:DISCNDosage:CAPSULE;ORALStrengthEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 8, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 8, 1994TE: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 ➤ 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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Cipla
US Department of Justice
QuintilesIMS
Colorcon
Medtronic
Healthtrust
Fuji
Boehringer Ingelheim

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