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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019675

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NDA 019675 describes ZANTAC, which is a drug marketed by Glaxo Grp Ltd, Teligent, Glaxosmithkline, and Sanofi Us, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the ZANTAC profile page.

The generic ingredient in ZANTAC 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: 019675

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 15MG BASE/ML
Approval Date:Dec 30, 1988TE:AARLD:Yes

Expired Orange Book Patents for NDA: 019675

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19885,068,249*PED► Subscribe
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19884,128,658► Subscribe
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19884,585,790*PED► Subscribe
Glaxo Grp Ltd
ZANTAC
ranitidine hydrochloride
SYRUP;ORAL019675-001Dec 30, 19884,521,431*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Argus Health
McKesson
US Department of Justice
UBS
US Army
Daiichi Sankyo
Mallinckrodt
Moodys
Novartis
Cipla

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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