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Last Updated: October 1, 2020

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Details for New Drug Application (NDA): 021224

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NDA 021224 describes RAZADYNE, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from two suppliers. Additional details are available on the RAZADYNE profile page.

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 021224
Tradename:RAZADYNE
Applicant:Janssen Pharms
Ingredient:galantamine hydrobromide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021224

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2001TE:RLD:No

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