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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 021698


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NDA 021698 describes ZANTAC 150, which is a drug marketed by Glaxosmithkline, Glaxo Grp Ltd, and Chattem Sanofi, and is included in four NDAs. Additional details are available on the ZANTAC 150 profile page.

The generic ingredient in ZANTAC 150 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 021698
Tradename:ZANTAC 150
Applicant:Chattem Sanofi
Ingredient:ranitidine hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Aug 31, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 13, 2007TE:RLD:Yes

Expired US Patents for NDA 021698

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chattem Sanofi ZANTAC 150 ranitidine hydrochloride TABLET;ORAL 021698-002 Mar 13, 2007 5,098,715 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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