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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020745

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NDA 020745 describes ZANTAC 75, which is a drug marketed by Sanofi Us and is included in two NDAs. It is available from five suppliers. Additional details are available on the ZANTAC 75 profile page.

The generic ingredient in ZANTAC 75 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-two suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 020745
Tradename:ZANTAC 75
Applicant:Sanofi Us
Ingredient:ranitidine hydrochloride
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EFFERVESCENT;ORALStrengthEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 26, 1998TE:RLD:Yes

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