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Serving leading biopharmaceutical companies globally:

Medtronic
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Baxter
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Cantor Fitzgerald
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Generated: December 17, 2017

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 suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 020095

Tradename:2
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary 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150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 020095

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GlaxosmithklineZANTAC 150ranitidine hydrochlorideCAPSULE;ORAL020095-001Mar 8, 1994► Subscribe► Subscribe
GlaxosmithklineZANTAC 300ranitidine hydrochlorideCAPSULE;ORAL020095-002Mar 8, 1994► Subscribe► Subscribe
GlaxosmithklineZANTAC 300ranitidine hydrochlorideCAPSULE;ORAL020095-002Mar 8, 1994► Subscribe► Subscribe
GlaxosmithklineZANTAC 300ranitidine hydrochlorideCAPSULE;ORAL020095-002Mar 8, 1994► Subscribe► Subscribe
GlaxosmithklineZANTAC 150ranitidine hydrochlorideCAPSULE;ORAL020095-001Mar 8, 1994► Subscribe► Subscribe
GlaxosmithklineZANTAC 150ranitidine hydrochlorideCAPSULE;ORAL020095-001Mar 8, 1994► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
Baxter
Julphar
Chubb
Express Scripts
Deloitte
Chinese Patent Office
Citi
McKinsey
Merck

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