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Generated: July 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020251

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NDA 020251 describes ZANTAC 25, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. Additional details are available on the ZANTAC 25 profile page.

The generic ingredient in ZANTAC 25 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-one suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for NDA: 020251

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:TABLET, EFFERVESCENT;ORALStrengthEQ 150MG BASE
Approval Date:Mar 31, 1994TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GRANULE, EFFERVESCENT;ORALStrengthEQ 150MG BASE/PACKET
Approval Date:Mar 31, 1994TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EFFERVESCENT;ORALStrengthEQ 25MG BASE
Approval Date:Apr 1, 2004TE:RLD:No

Expired Orange Book Patents for NDA: 020251

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-001Mar 31, 1994► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
GRANULE, EFFERVESCENT;ORAL020251-002Mar 31, 1994► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
GRANULE, EFFERVESCENT;ORAL020251-002Mar 31, 1994► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-001Mar 31, 1994► Subscribe► Subscribe
Glaxo Grp Ltd
ZANTAC 150
ranitidine hydrochloride
TABLET, EFFERVESCENT;ORAL020251-001Mar 31, 1994► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Merck
Express Scripts
Citi
Medtronic
Healthtrust
US Department of Justice
Covington
Queensland Health
Johnson and Johnson
Colorcon

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.

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